| View |
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DR-XY48247
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Ascorbic acid + Zinc + Colecalciferol (Vitamin D3)
|
None
|
500 mg (equivalent to 568.18 mg Sodium Ascorbate)/10 mg (equivalent 27.5 mg Zinc Sulfate monohydrate)/500 IU
|
Capsule
|
Vitamin/Mineral
|
Northfield Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
01 August 2022
|
01 August 2027
|
| View |
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DR-XY48248
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Docetaxel
|
Doxel
|
20 mg/mL
|
Concentrate for Solution for IV Infusion
|
Antineoplastic Agent
|
Sichuan Huiyu Pharmaceutical Company Limited
|
China
|
Initial
|
02 August 2022
|
02 August 2027
|
| View |
DR-XY48249_PI_01.pdf
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DR-XY48249
|
Sildenafil Citrate
|
None
|
50 mg
|
Orally Disintegrating Strip
|
-
|
Zim Laboratories Limited
|
India
|
Monitored Release
|
02 August 2022
|
02 August 2027
|
| View |
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DR-XY48250
|
Paracetamol
|
Osteomol
|
665 mg
|
Modified Release Tablet
|
Analgesic/ Antipyretic
|
Alkem Laboratories Limited
|
India
|
Monitored Release
|
02 August 2022
|
02 August 2027
|
| View |
|
DR-XY48251
|
Peritoneal Dialysis Solution with 1.5% Dextrose
|
None
|
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
|
Dialysis Solution
(Intraperitoneal)
|
Peritoneal Dialytic
|
Mitra Industries (P) Ltd.
|
India
|
Initial
|
03 August 2022
|
03 August 2027
|
| View |
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DR-XY48252
|
Peritoneal Dialysis Solution with 2.5% Dextrose
|
None
|
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
|
Dialysis Solution
(Intraperitoneal)
|
Peritoneal Dialytic
|
Mitra Industries (P) Ltd.
|
India
|
Initial
|
03 August 2022
|
03 August 2027
|
| View |
|
DR-XY48253
|
Peritoneal Dialysis Solution with 4.25% Dextrose
|
None
|
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
|
Dialysis Solution
(Intraperitoneal)
|
Peritoneal Dialytic
|
Mitra Industries (P) Ltd.
|
India
|
Initial
|
03 August 2022
|
03 August 2027
|
| View |
DR-XY48254_PI_01.pdf
|
DR-XY48254
|
Tenofovir alafenamide (as hemifumarate)
|
Tafnext
|
25 mg
|
Film Coated Tablet
|
Antiviral (Nucleoside/Nucleotide Reverse Transcriptase
|
Hetero Labs Limited (Unit-V, Block –VB)
|
India
|
Monitored Release (Correction)
|
27 October 2022
|
03 August 2027
|
| View |
|
DR-XY48255
|
Clindamycin (as phosphate)
|
Banbakt
|
100 mg
|
Vaginal Suppository
|
Antibiotic
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
03 August 2022
|
03 August 2027
|
| View |
DR-XY48256_PI_01.pdf
|
DR-XY48256
|
Colistimethate Sodium
|
None
|
384.61 mg [equivalent to 150 mg Colistin base]
|
Lyophilized Powder for Injection
(I.M./I.V.)
|
Antibacterial
|
Aspiro Pharma Limited SY.
|
India
|
Monitored Release
|
03 August 2022
|
03 August 2025
|
| View |
|
DR-XY48257
|
Alendronic Acid
|
None
|
70 mg/ 100 mL
|
Oral Solution
|
Bisphosphonate
|
Pinewood Laboratories Ltd.
|
Ireland
|
Monitored Release
|
04 August 2022
|
04 August 2027
|
| View |
|
DR-XY48258
|
Multivitamins + Minerals
|
None
|
500 mg
|
Capsule
|
-
|
Yue-Sheng Biotech Co., Ltd.
|
Taiwan
|
Initial (OTC)
|
04 August 2022
|
04 August 2027
|
| View |
|
DR-XY48259
|
Safinamide (as mesilate)
|
Equfina
|
50mg
|
Film-Coated Tablet
|
-
|
Meiji Seika Pharma Co., Ltd. (Odawara Plant)
|
Japan
|
Monitored Release
|
04 August 2022
|
04 August 2027
|
| View |
|
DR-XY48260
|
Rizatriptan
|
Migratan
|
10 mg
|
Tablet
|
Antimigraine (Selective serotonin (5HT1) agonist]
|
Cadila Healthcare Limited
|
India
|
Monitored Release
|
05 August 2022
|
05 August 2025
|
| View |
DR-XY48261_PI_01.pdf
|
DR-XY48261
|
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 |
|
DR-XY48262
|
Ranolazine
|
Razine
|
500 mg
|
Extended-Release Tablet
|
Anti-Anginal
|
Ajanta Pharma Limited
|
India
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DR-XY48263
|
Multivitamins + Amino Acids + Iron + Guarana
|
Stressaide
|
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 |
|
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
|