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DRP-48946
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Multivitamins + Minerals
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Nutiplete
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Formulation
Each Tablet contains:
Ascorbic Acid (Vitamin C)
dl-alpha Tocopheryl (as acetate) (Vitamin E)
200 mg 50 IU
Manganese (as sulfate monohydrate)
3 mg
Copper (as cupric oxide)
1 mg
Beta Carotene (Vitamin A)
2000 IU
Vitamin Ki
75 mcg
Selenium (as sodium selenite) Zinc (as zinc oxide)
70 mcg
15 mcg
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Tablet
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Vitamins/Minerals
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The Acme Laboratories Ltd.
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Bangladesh
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Initial (Correction)
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26 September 2024
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09 January 2029
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DRHR-2315
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Benzydamine (as hydrochloride)
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Difflam Lemon
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3mg
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Lozenges
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Throat Preparation
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Unique Pharmaceuticals Laboratories (Division of
J.B. Chemicals & Pharmaceuticals Ltd.)
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Singapore
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Initial
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09 January 2024
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09 January 2029
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DRP-14731
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Paracetamol
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Pyromed
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120mg/5mL
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Syrup
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-
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Interphil Laboratories, Inc.
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Philippines
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Initial
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09 January 2024
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09 January 2029
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DRP-14730
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Paracetamol
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Pyromed Kids
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250 mg/5 mL
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Syrup (Raspberry Flavor)
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Analgesic/Antipyretic
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Interphil Laboratories, Inc.
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Philippines
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Initial
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09 January 2024
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09 January 2029
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DRP-14729
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Ascorbic Acid + Zinc + Cholecalciferol
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Sydend3 Pluz
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500 mg (equivalent to 562.5 mg Sodium Ascorbate)/ 10 mg (equivalent to 27.45 mg Zinc Sulfate Monohydrate)/1000 IU
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Capsule
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-
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Sydenham Laboratories, Inc.
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Philippines
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Initial
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29 January 2024
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09 January 2029
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DRP-14770
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Olmesartan Medoxomil + Amlodipine (as besilate)
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Amlopril
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20 mg/5 mg
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Film-Coated Tablet
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-
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Globela Pharma Private Limited
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India
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Initial
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09 January 2024
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09 January 2029
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DRP-14769
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Olmesartan Medoxomil + Amlodipine (as besilate)
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Amlopril
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40 mg/5 mg
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Film-Coated Tablet
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-
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Globela Pharma Private Limited
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India
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Initial
|
09 January 2024
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09 January 2029
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DRP-14791
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Moxifloxacin (as
Hydrochloride)
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Moxidrop
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5 mg/mL (0.5% w/v)
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Ophthalmic Solution (Eye Drops)
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-
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Skymap Healthcare Pvt. Ltd.
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India
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Initial
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09 January 2024
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09 January 2029
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DRP-14768
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Olmesartan Medoxomil + Amlodipine (as besilate)
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Amlopril
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40 mg/ 10 mg
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Film Coated Tablet
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-
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Globela Pharma Private Limited
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India
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Initial
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09 January 2024
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09 January 2029
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DRP-14696
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Dexamethasone Phosphate (As Sodium)
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Dexago
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4 mg/mL (8 mg/2 mL)
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Solution for Injection (I.V./I/M.)
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Corticosteroid
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Makcur Laboratories Limited
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India
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Initial
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10 January 2024
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10 January 2029
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| View |
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DRP-14799
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Multivitamins
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Ebavit
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Formulation
Each capsule contains:
Retinol acetate (Vitamin A) 1750 IU (equivalent to 525 meg of Retinol Acetate)
Cholecalciferol (Vitamin D3) 400 IU (equivalent to 10 mg of Cholecalciferol)
DI-Alpha Tocopheryl Acetate (Vitamin E) 10 IU (equivalent to 10 mg of DI-Alpha Tocopheryl Acetate)
Ascorbic Acid (Vitamin C) 80 mg
Niacinamide (Vitamin B3) 20 mg
Pyridoxine hydrochloride (Vitamin B6) 2 mg
Thiamine mononitrate (Vitamin B1) 1.30 mg
Riboflavin (Vitamin B2) 130mg
Folic Acid (Vitamin B9) 170 mcg
Cyanocobalamin (Vitamin B12) 5 mcg
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Capsule
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Vitamins
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Azarias Pharmaceutical Laboratories Inc.,
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Philippines
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Initial
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10 January 2024
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10 January 2029
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DRP-14800
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Multivitamins + Minerals
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Ebaminvit
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Formulation
Each film-coated tablet contains.
Retinol acetate (Vitamin A) 5,000 IU (equivalent to 10 mg of Retinol Acetate)
Cholecalciferol (Vitamin D3) 400 IU (equivalent to 4 mg of Cholecalciferol)
d-Alpha Tocopherol (Vitamin E) 10 IU (equivalent to 14.29 mg of d-Alpha Tocopherol}
Ascorbic Acid (Vitamin C) 50 mg
Nicotinamide 20 mg
Calcium Pantothenate 5 mg
Thiamine mononitrate (Vitamin B1) 2.50 mg
Riboflavin (Vitamin B2) 2.50 mg
Pyridoxine hydrochloride (Vitamin B6) 500 mcg
Cyanocobalamin (Vitamin B12) 2 mcg
Calcium 35 mg (equivalent to 87 50 mg Calcium Carbonate)
Iron 10 mg (equivalent to 30 mg Ferrous Fumarate)
Magnesium 6 mg (equivalent to 20 82 mg Magnesium Carbonate)
Potassium 5 mg (equivalent to 9.55 mg Potassium Chloride)
Manganese 1 mg (equivalent to 3.076 mg Manganese Sulfate Monohydrate)
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Film-Coated Tablet
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Vitamin/ Mineral
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Azarias Pharmaceutical Laboratories Inc.,
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Philippines
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Initial
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10 January 2024
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10 January 2029
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DRP-14801
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Rasagiline (as mesilate)
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Relzin
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1 mg
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Tablet
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Anti-Parkinson Drug (Monoamine Oxidase B Inhibitor)
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Zydus Lifesciences Limited
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India
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Initial
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11 January 2024
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11 January 2029
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| View |
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DR-XY48976
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Dolutegravir (as sodium) + Lamivudine + Tenofovir
Disoproxil (as fumarate)
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None
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50 mg/300 mg/300 mg
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Film-Coated Tablet
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Direct Acting Antiviral
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Aurobindo Pharma Limited -Unit X
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India
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Monitored release
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10 January 2024
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10 January 2029
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DR-XY48974
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Roflumilast
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Rolfutor 500
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500 mcg
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Tablet
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Drug for Obstructive Airway Diseases
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Torrent Pharmaceuticals Ltd.
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India
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Initial
|
11 January 2024
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11 January 2029
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| View |
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DRP-14802
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Ondansetron (as hydrochloride dihydrate)
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Ondero
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2 mg/mL
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Solution for Injection (I.M./I.V.)
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Antiemetic/Antinauseant [Serotonin (5HT3) Antagonist]
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Aspiro Pharma Limited
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India
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Initial
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11 January 2024
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11 January 2029
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| View |
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DR-XY48975
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Rosuvastatin (as calcium)
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Rovastin
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20 mg
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Film-Coated Tablet
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Lipid Modifying Agent (HMG CoA Reductase Inhibitor)
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Hizon Laboratories, Inc.
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Philippines
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Initial
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11 January 2024
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11 January 2029
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| View |
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DR-XY48953
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Ferrous sulfate + Folic acid
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None
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200 mg (equivalent to 60 mg elemental Iron) 400 mcg
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Film-Coated Tablet
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Anti-Anemic
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Medicamen Organics Limited (Unit 1)
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India
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Initial
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11 January 2024
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11 January 2029
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| View |
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DRP-14803
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Ketoconazole
|
Novazol
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20 mg/g (2% w/w)
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Cream
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Antifungal
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S Kant Healthcare Ltd.
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India
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Initial [OTCI]
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11 January 2024
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11 January 2029
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| View |
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DRP-14807
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Irinotecan Hydrochloride (as trihydrate)
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None
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20 mg/mL (100 mg/5 mL)
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Concentrate Solution for IV Infusion
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Antineoplastic
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Shilpa Medicare Limited (Unit-4, Pharmaceutical
Formulations Sez)
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India
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Initial
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12 January 2024
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12 January 2029
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