View |
|
DRP-8752
|
Clomifene Citrate
|
Fertab-50
|
50 mg
|
Tablet
|
Ovulation Stimulant
|
Oman Pharmaceutical Products Co. L.L.C.
|
Oman
|
Renewal
|
30 June 2024
|
30 July 2029
|
View |
|
DRP-8770
|
Gemcitabine (As Hydrochloride)
|
Gemosanz-200
|
200 mg
|
Powder For Solution For Iv Infusion
|
Antineoplastic (Cell Cycle-Specific Agent)
|
Admac Lifesciences
|
India
|
Automatic Renewal
|
13 October 2022
|
07 November 2028
|
View |
|
DRP-8772
|
Azithromycin (As Dihydrate)
|
Azilide-250
|
250mg
|
Film Coated Tablet
|
Antibacterial (Macrolide)
|
Micro Labs Limited
|
India
|
Automatic Renewal
|
20 July 2023
|
19 December 2028
|
View |
|
DRP-8456-01
|
Diclofenac Potassium
|
Clofenova
|
50mg
|
Film-Coated Tablet
|
Non-Steroidal Anti-Inflammatory Drugs (NSAID)
|
Saga Laboratories
|
India
|
Renewal
|
05 November 2023
|
28 November 2028
|
View |
|
DRP-1094-01
|
Gabapentin
|
Unbranded
|
300 mg
|
Capsule
|
Anticonvulsant / Antiepileptic
|
Sun Pharmaceutical Industries Limited
|
India
|
Renewal
|
05 November 2023
|
19 October 2028
|
View |
|
DRP-8662-01
|
Levetiracetam
|
None
|
750 mg
|
Film-coated Tablet
|
Antiepileptic
|
Sun Pharmaceutical Industries Ltd.
|
India
|
Renewal
|
09 June 2022
|
09 May 2027
|
View |
|
DRP-8666-01
|
Topiramate
|
Unbranded
|
25 mg
|
Film-coated Tablet
|
Anticonvulsant/ Antiepileptic
|
Sun Pharmaceutical Industries Limited
|
India
|
Renewal
|
07 March 2023
|
11 February 2028
|
View |
|
DRP-9029-01
|
Rosuvastatin (as Calcium)
|
Astadix 20
|
20 mg
|
Film-Coated Tablet
|
-
|
Zim Laboratories Limited
|
India
|
-
|
01 October 2021
|
18 August 2025
|
View |
|
DRP-9504-01
|
Cefalexin (As Monohydrate)
|
None
|
125 mg / 5 mL
|
Powder For Oral Suspension
|
-
|
Asian Antibiotics, Inc.
|
Philippines
|
-
|
07 October 2021
|
31 August 2025
|
View |
|
DRP-10478
|
Metformin hydrochloride
|
Metxr 500
|
500mg
|
Extended Release Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial (Re-issuance)
|
18 August 2022
|
30 September 2026
|
View |
|
DRP-10477
|
Metformin hydrochloride
|
Glyformet
|
1 g
|
Extended Release Tablet
|
Oral hypoglycemic Agent (Biguanide)
|
Globela Pharma Private Limited
|
India
|
Automatic Renewal
|
07 April 2022
|
30 September 2026
|
View |
DRP-10486_PIL_01.pdf
|
DRP-10486
|
Ascorbic Acid + Zinc + Cholecalciferol (Vitamin D3)
|
Sovit-Pro
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/ 25 mg (equivalent to 68.62 Zinc Sulfate Monohydrate)/
1,000 IU
|
Capsule
|
-
|
San Marino Laboratories Corporation
|
Philippines
|
Automatic Renewal
|
07 April 2022
|
04 October 2026
|
View |
|
DRP-10479
|
Metformin hydrochloride
|
Metfn
|
1g
|
Film-coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial (Re-issuance)
|
18 August 2022
|
30 September 2026
|
View |
|
DR-XY47447
|
Cetirizine + Phenylephrine Hydrochloride
|
Zyriz Plus
|
5 mg/5 mg per 5 mL
|
Syrup (Banana Flavor)
|
-
|
Hizon Laboratories, Inc.
|
Philippines
|
-
|
16 February 2022
|
08 October 2026
|
View |
|
DRP-7495-01
|
Cilostazol
|
None
|
100 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
01 October 2021
|
16 April 2025
|
View |
|
DRP-9244-01
|
Salbutamol (As Sulfate)
|
Arkasol
|
1mg/mL (2.5mg/2.5mL)
|
Solution For Inhalation
|
-
|
Legency Remedies Pvt. Ltd.
|
India
|
-
|
06 October 2021
|
09 June 2025
|
View |
|
DRP-8257-02
|
Citicoline (as sodium)
|
Zytalev
|
500 mg
|
Film-Coated Tablet
|
CNS Stimulant/Neuroprotective Agent
|
Theon Pharmaceuticals Limited
|
India
|
Renewal
|
27 May 2024
|
09 July 2029
|
View |
|
DRP-6446-01
|
Dexchlorpheniramine Maleate + Betamethasone
|
None
|
2 mg/250 mcg per 5 mL
|
Syrup
|
-
|
Norris Medicines Ltd.
|
India
|
Initial
|
06 October 2021
|
26 November 2025
|
View |
|
DRP-10496
|
Paracetamol
|
Glopar
|
500mg
|
Effervescent Tablet (Orange Flavor)
|
-
|
Globela Pharma Private Limited
|
India
|
-
|
06 October 2021
|
06 October 2026
|
View |
|
DR-XY47446
|
Cholecalciferol
(Vitamin D3)
|
CalPro-D
|
2,000 IU
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC](Reconstruction)
|
05 August 2022
|
08 October 2026
|