| View |
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BRP-074-02
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Insulin Human (DNA)
|
Duosulin 30:70
|
100 IU/mL
(30% Soluble Insulin Human / 70% Isophane Insulin
Human)
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Suspension for Injection (IM/SC)
|
-
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M.J. Biopharm Pvt., Ltd.
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India
|
-
|
04 May 2022
|
23 February 2027
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| View |
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HMR-172
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Vitex Negundo L. (Lagundi Leaf)
|
Plemex Tablet
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600mg
|
Tablet
|
-
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Northfield Laboratories Inc.
|
Philippines
|
-
|
29 April 2022
|
29 April 2027
|
| View |
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DRP-11794
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Multivitamins+Minerals
|
Sureboost Daily
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Formulation Each effervescent tablet contains: Ascorbic Acid (Vitamin C)-75mg Alpha Tocopheryl Acetate (Vitamin E)-12mg Nicotinamide-10mg Pyridoxine Hydrochloride (Vitamin B6)-2.5mg Thiamine Hydrochloride (Vitamin B1)-1.5mg Riboflavin Sodium Phosphate (Vitamin B2)-1mg Vitamin A-0.25mg
Folic Acid (Vitamin B9)-100mcg Cyanocobalamin (Vitamin B12)-2.5mcg Magnesium (as Dried Magnesium Glycerosphosphate)-10mg Iron (as Ferrous Gluconate)-1.5mg Zinc (as Zinc Sulfate Monohydrate)-1.5mg Manganese (as Manganese Sulfate Monohydrate)-0.5mg Copper (as Anhydrous Copper Sulfate)-0.25mg
|
Effervescent Tablet
|
Vitamins/ Minerals
|
Vovantis Laboratories Private Limited
|
India
|
Initial (OTC)
|
29 April 2022
|
29 April 2027
|
| View |
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DR-XY47987
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500mg (equivalent to 200mg Ascorbic Acid and 300mg Sodium Ascorbate)
|
Khrizvitcee 500
|
500 mg
|
Chewable Tablet
|
-
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Reyoung Pharmaceutical Co., Ltd.
|
China
|
-
|
29 April 2022
|
29 April 2027
|
| View |
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DRP-11828
|
Cetirizine Dihydrochloride
|
None
|
10 mg
|
Film-Coated Tablet
|
Antihistamine
|
Sydler Remedies Pvt. Limited
|
India
|
Initial
|
06 May 2022
|
06 May 2025
|
| View |
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DRP-11825
|
Hypromellose
|
Mellotears
|
3 mg/mL (0.3% w/v)
|
Ophthalmic Solution
|
Ophthalmic Solution
|
Indiana Ophthalmics
|
India
|
Initial (OTC)
|
05 May 2022
|
05 May 2027
|
| View |
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DRP-11796
|
Ascorbic Acid
|
None
|
Alu/Deep Red PVC Blister Pack x 10's (Box of 30's, 50's and 100's)
|
Chewablet Tablet
|
Vitamin
|
Azarias Pharmaceutical Laboratories Inc,
|
Philippines
|
Initial (OTC)
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11795
|
Ascorbic Acid
|
Rapid-C1000
|
1000mg (equivalent to 600mg Ascorbic Acid and 450mg Sodium Ascorbate)
|
Chewable Tablet
|
Vitamin
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11827
|
Ascorbic Acid
|
Ascorgen1000
|
1000mg (equivalent to 600mg Ascorbic Acid and 450mg Sodium Ascorbate)
|
Chewable Tablet
|
Vitamin
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)
|
06 May 2022
|
06 May 2027
|
| View |
|
DRP-11797
|
Betahistine hydrochloride
|
VERTset
|
24mg
|
Tablet
|
Antivertigo
|
Globela Pharma Private Limited
|
India
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11803
|
Phenylpropanolamine Hydrochloride/Brompheniramine Maleate
|
Nostero
|
6.25mg / 2mg per mL
|
Syrup (Drops)
|
Decongestant/Antihistamine
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal (Variation: PCPR Conversion)
|
29 April 2022
|
07 September 2026
|
| View |
|
DR-XY47996
|
Paracetamol + Thiamine Mononitrate (Vitamin B1) +
Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Dolo-Neurobion3B®
|
500mg/ 50mg / 100mg / 100mcg
|
Film-Coated Tablet
|
Analgesic/Antipyretic/Vitamins
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC) correction
|
02 August 2022
|
05 May 2027
|
| View |
|
DRP-11809
|
Mesna
|
Urosaph
|
100 mg/mL (400 mg/4mL)
|
Solution for Injection (I.V.)
|
-
|
Bruck Pharma Private Limited
|
India
|
-
|
02 May 2022
|
02 May 2027
|
| View |
|
DRP-11807
|
Methotrexate
|
Saphtotrexate
|
25 mg/mL
|
Solution for Injection (I.M./I.V.)
|
Antineoplastic
|
Bruck Pharma Private Limited
|
India
|
Initial
|
02 May 2022
|
02 May 2027
|
| View |
|
DRP-11826
|
Ascorbic Acid + Zinc
|
None
|
500mg (equivalent to 562.42mg Sodium Ascorbate) / 10mg (equivalent to 27.50mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin / Mineral
|
AM-Europharma Corporation
|
Philippines
|
Initial (OTC)
|
05 May 2022
|
05 May 2027
|
| View |
|
DRP-11813
|
Telmisartan + Amlodipine (as besilate)
|
Telmisaph-A45
|
40 mg/5mg
|
Tablet
|
Angiotensin II antagonist/Calcium Channel Blocker
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
02 May 2022
|
02 May 2027
|
| View |
|
DRP-11802
|
Multivitamins + Zinc
|
Rizinc Plus
|
Formulation: Each 5 mL (1 teaspoonful) contains: Retinol Palmitate (Vitamin A) Cholecalciferol Vitamin D3) dl-c-Tocopheryl Acetate (Vitamin E) Ascorbic Acid (Vitamin C) Lysine Taurine Niacin Zinc (equivalent to 13.75 mg Zinc Sulfate Monohydrate)
1300 IU 260 IU LIU
Thiamine Hydrochloride (Vitamin B) Riboflavin (Vitamin B2) Pyridoxine Hydrochloride (Vitamin B:) Cyanocobalamin (Vitamin B12)
I mg 1 mg I mg 1 mg
60 mg 25 mg 25 mg 10 mg 5 mg
|
Syrup
|
Vitamins/ Mineral
|
Diamond Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
13 May 2022
|
29 April 2027
|
| View |
|
DRP-11022
|
Omeprazole (as sodium)
|
Morzole-40
|
40 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Proton Pump Inhibitor
|
Mason Pharma
|
India
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11786
|
Pantoprazole (as sodium sesquihydrate)
|
Morpan-40
|
40 mg
|
Powder For Injection (Lyophilized)
|
Proton Pump Inhibitor (PPI)
|
Mason Pharma
|
India
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11789
|
Dapagliflozin
|
Dapasaph-10
|
10 mg
|
Film-Coated Tablet
|
Anti-Diabetic
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
29 April 2022
|
29 April 2027
|