View |
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DR-XY48247
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Ascorbic acid + Zinc + Colecalciferol (Vitamin D3)
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None
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500 mg (equivalent to 568.18 mg Sodium Ascorbate)/10 mg (equivalent 27.5 mg Zinc Sulfate monohydrate)/500 IU
|
Capsule
|
Vitamin/Mineral
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Northfield Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
01 August 2022
|
01 August 2027
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View |
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DR-XY48248
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Docetaxel
|
Doxel
|
20 mg/mL
|
Concentrate for Solution for IV Infusion
|
Antineoplastic Agent
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Sichuan Huiyu Pharmaceutical Company Limited
|
China
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Initial
|
02 August 2022
|
02 August 2027
|
View |
DR-XY48249_PI_01.pdf
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DR-XY48249
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Sildenafil Citrate
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None
|
50 mg
|
Orally Disintegrating Strip
|
-
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Zim Laboratories Limited
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India
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Monitored Release
|
02 August 2022
|
02 August 2027
|
View |
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DR-XY48250
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Paracetamol
|
Osteomol
|
665 mg
|
Modified Release Tablet
|
Analgesic/ Antipyretic
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Alkem Laboratories Limited
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India
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Monitored Release
|
02 August 2022
|
02 August 2027
|
View |
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DR-XY48251
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Peritoneal Dialysis Solution with 1.5% Dextrose
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None
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Formulation: Each 100 mL contains:
Dextrose Anhydrous, BP Sodium Chloride, BP Sodium Lactate, BP Calcium Chloride, BP Magnesium Chloride, BP
1.5 g 538 mg 448 mg 25.7 mg 5.08 mg
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Dialysis Solution
(Intraperitoneal)
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Peritoneal Dialytic
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Mitra Industries (P) Ltd.
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India
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Initial
|
03 August 2022
|
03 August 2027
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View |
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DR-XY48252
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Peritoneal Dialysis Solution with 2.5% Dextrose
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None
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Formulation: Each 100 mL contains:
Dextrose Anhydrous, BP Sodium Chloride, BP Sodium Lactate, BP Calcium Chloride, BP Magnesium Chloride, BP
538 mg 448 mg 25.7 mg 5.08 mg
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Dialysis Solution
(Intraperitoneal)
|
Peritoneal Dialytic
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Mitra Industries (P) Ltd.
|
India
|
Initial
|
03 August 2022
|
03 August 2027
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View |
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DR-XY48253
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Peritoneal Dialysis Solution with 4.25% Dextrose
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None
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Formulation: Each 100 mL contains:
Dextrose Anhydrous, BP Sodium Chloride, BP Sodium Lactate, BP Calcium Chloride, BP Magnesium Chloride, BP
538 mg 448 mg 25.7 mg 5.08 mg
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Dialysis Solution
(Intraperitoneal)
|
Peritoneal Dialytic
|
Mitra Industries (P) Ltd.
|
India
|
Initial
|
03 August 2022
|
03 August 2027
|
View |
DR-XY48254_PI_01.pdf
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DR-XY48254
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Tenofovir alafenamide (as hemifumarate)
|
Tafnext
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25 mg
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Film Coated Tablet
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Antiviral (Nucleoside/Nucleotide Reverse Transcriptase
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Hetero Labs Limited (Unit-V, Block –VB)
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India
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Monitored Release (Correction)
|
27 October 2022
|
03 August 2027
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View |
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DR-XY48255
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Clindamycin (as phosphate)
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Banbakt
|
100 mg
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Vaginal Suppository
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Antibiotic
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Kusum Healthcare Pvt. Ltd.
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India
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Monitored Release
|
03 August 2022
|
03 August 2027
|
View |
DR-XY48256_PI_01.pdf
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DR-XY48256
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Colistimethate Sodium
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None
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384.61 mg [equivalent to 150 mg Colistin base]
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Lyophilized Powder for Injection
(I.M./I.V.)
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Antibacterial
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Aspiro Pharma Limited SY.
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India
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Monitored Release
|
03 August 2022
|
03 August 2025
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View |
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DR-XY48257
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Alendronic Acid
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None
|
70 mg/ 100 mL
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Oral Solution
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Bisphosphonate
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Pinewood Laboratories Ltd.
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Ireland
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Monitored Release
|
04 August 2022
|
04 August 2027
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View |
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DR-XY48258
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Multivitamins + Minerals
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None
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500 mg
|
Capsule
|
-
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Yue-Sheng Biotech Co., Ltd.
|
Taiwan
|
Initial (OTC)
|
04 August 2022
|
04 August 2027
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View |
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DR-XY48259
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Safinamide (as mesilate)
|
Equfina
|
50mg
|
Film-Coated Tablet
|
-
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Meiji Seika Pharma Co., Ltd. (Odawara Plant)
|
Japan
|
Monitored Release
|
04 August 2022
|
04 August 2027
|
View |
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DR-XY48260
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Rizatriptan
|
Migratan
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10 mg
|
Tablet
|
Antimigraine (Selective serotonin (5HT1) agonist]
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Cadila Healthcare Limited
|
India
|
Monitored Release
|
05 August 2022
|
05 August 2025
|
View |
DR-XY48261_PI_01.pdf
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DR-XY48261
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Rosuvastatin (as calcium) + Ezetimibe
|
Zevas
|
10 mg/10 mg
|
Film-Coated Tablet
|
Lipid Modifying Agents
|
Aju Pharm Co., Ltd.
|
Korea
|
Monitored Release
|
05 August 2022
|
05 August 2027
|
View |
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DR-XY48262
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Ranolazine
|
Razine
|
500 mg
|
Extended-Release Tablet
|
Anti-Anginal
|
Ajanta Pharma Limited
|
India
|
Initial
|
08 August 2022
|
08 August 2027
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View |
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DR-XY48263
|
Multivitamins + Amino Acids + Iron + Guarana
|
Stressaide
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Formulation Each Film-Coated Tablet contains: Retinyl Acetate (Vitamin A) dl-alpha Tocopheryl Acetate (Vitamin E) Thiamine Mononitrate (Vitamin B1) Riboflavin (Vitamin B2) Pyridoxine Hydrochloride (Vitamin B6) Cyanocobalamin (Vitamin B12) Niacinamide (Vitamin B3)
1500 IU 5 IU 5 mg 3 mg 1.5 mg 5 mcg 20 mg
Calcium Pantothenate (Vitamin B5) Iron (as Carbonyl) (Ferronyl Iron) Methionine (as Racemethionine) Lysine (as Hydrochloride) Debittered Brewer's Yeast Guarana
10 mg 8 mg 5 mg 2.25 mg 25 mg 100 mg
|
Film-Coated Tablet
|
Vitamins / Minerals
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
09 August 2022
|
09 August 2027
|
View |
|
DR-XY48264
|
Oxaliplatin
|
Oxalibil
|
5 mg/ mL (100 mg/20 mL)
|
Concentrate for Solution for
Intravenous (IV) Infusion
|
Antineoplastic Agent (Platinum Compound)
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
09 August 2022
|
09 August 2027
|
View |
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DR-XY48265
|
Fingolimod (as hydrochloride)
|
Finmod
|
500 mcg
|
Capsule
|
Selective Immunosuppressant
|
Hetero Labs Limited
|
India
|
Initial
|
09 August 2022
|
09 August 2027
|
View |
|
DR-XY48266
|
Escitalopram (As Oxalate)
|
Escit
|
20mg
|
Film Coated Tablets
|
-
|
Celogen Generics Private Ltd.
|
India
|
Initial
|
10 August 2022
|
10 August 2027
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