| View |
|
DRP-13691
|
Ofloxacin
|
Ofiyana
|
3 mg/mL (0.3% w/v)
|
Ophthalmic Solution
|
-
|
Indiana Ophthalmics
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
DRP-13842
|
Rabeprazole sodium
|
Rabezo
|
20 mg
|
Enteric-Coated Tablet
|
-
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
28 April 2023
|
28 April 2028
|
| View |
|
DRP-13692
|
Azithromycin (as dihydrate)
|
Azeeya-500
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Macrolide)
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
DRP-13838_PI_01.pdf
|
DRP-13838
|
Pregabalin
|
Rebalin 150
|
150 mg
|
Capsule
|
Antiepileptic
|
Sunglow Lifescience Private Limited
|
India
|
Initial (Reconstruction)
|
10 September 2024
|
27 April 2028
|
| View |
DR-XY48709_PI_01.pdf
|
DR-XY48709
|
Dacomitinib (as monohydrate)
|
Vizimpro
|
15 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Epidermal Growth Receptor (EGFR) Tyrosine kinase Inhibitor)
|
Pfizer Manufacturing Deutschland GMBH
|
Germany
|
Monitored Release (MR) (Corrections)
|
13 February 2024
|
25 April 2028
|
| View |
DR-XY48710_PI_01.pdf
|
DR-XY48710
|
Dacomitinib (as monohydrate)
|
Vizimpro
|
30 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Epidermal Growth Factor Receptor (EGFR) Tyrosine kinase Inhibitor)
|
Pfizer Manufacturing Deutschland GMBH
|
Germany
|
Monitored Release (MR) (Corrections)
|
13 February 2024
|
25 April 2028
|
| View |
DR-XY48708_PI_01.pdf
|
DR-XY48708
|
Dacomitinib (as monohydrate)
|
Vizimpro
|
45 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Epidermal Growth Factor Receptor (EGFR) Tyrosine kinase Inhibitor)
|
Pfizer Manufacturing Deutschland GMBH
|
Germany
|
Monitored Release (MR) (Corrections)
|
13 February 2024
|
25 April 2028
|
| View |
|
DRP-13837
|
Sitagliptin (as phosphate monohydrate)
|
Sitadin
|
100 mg
|
Film-Coated Tablet
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
27 April 2023
|
27 April 2028
|
| View |
|
DRP-13772
|
Dorzolamide (as hydrochloride)
|
Lumedor
|
20 mg/mL (2% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Antiglaucoma (Carbonic anhydrase inhibitor)
|
Axa Parenterals Limited
|
India
|
Initial (Reconstruction)
|
12 August 2024
|
17 April 2028
|
| View |
|
DRP-13785
|
Memantine Hydrochloride
|
Timantine
|
10 mg
|
Film-Coated Tablet
|
-
|
Titan Laboratories Pvt. Ltd.
|
India
|
Initial
|
19 April 2023
|
19 April 2028
|
| View |
|
DRP-13774
|
Dexamethasone + Neomycin (as sulfate) + Polymyxin B Sulfate
|
Neladex
|
1 mg/3.5 mg/6,000 IU per mL
|
Ophthalmic Suspension
(Eye Drops)
|
-
|
World Medicine Ilac Sanayi ve Ticaret A.S.
|
Turkey
|
Initial
|
17 April 2023
|
17 April 2028
|
| View |
|
DRP-13798
|
Sevelamer Carbonate
|
Revlomer
|
800 mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
28 April 2023
|
28 April 2028
|
| View |
|
DRP-13786
|
Fluorouracil
|
Fin-5FU
|
50 mg/mL (500 mg/10 mL)
|
Solution For Injection (I.V.)
|
-
|
Venus Remedies Limited
|
India
|
Initial
|
19 April 2023
|
19 April 2028
|
| View |
|
DRP-13796
|
Salbutamol (as sulfate) + Bromhexine Hydrochloride + Guaifenesin
|
Tricentisaph
|
2 mg/ 4 mg/ 100 mg per 5 mL
|
Syrup
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
24 April 2023
|
24 April 2028
|
| View |
|
DRP-13809
|
Clarithromycin
|
Clarisaph-500
|
500 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
26 April 2023
|
26 April 2028
|
| View |
|
DRP-13777
|
Glutathione (reduced)
|
Guthione
|
600 mg
|
Lyophilized Powder for Injection (I.M./I.V.)
|
-
|
BC World Pharm. Co., Ltd.
|
Korea
|
Initial
|
17 April 2023
|
17 April 2028
|
| View |
|
DRP-13790
|
Doxorubicin hydrochloride
|
Fin-Dox 50
|
2 mg/mL (50 mg/25 mL)
|
Solution for IV Injection
|
Antineoplastic
|
Venus Remedies, Limited
|
India
|
Initial (Correction)
|
29 May 2024
|
20 April 2028
|
| View |
|
DRP-13773
|
Doxofylline
|
Doxokon
|
400 mg
|
Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
17 April 2023
|
17 April 2028
|
| View |
|
DRP-13690
|
0.9% Sodium Chloride
|
NACLO
|
900 mg/100 mL (0.9% w/v)
|
Solution for Intravenous
Infusion
|
-
|
Eurolife Healthcare Pvt. Ltd.
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
DRP-13771
|
Furosemide
|
Zemide
|
10 mg/mL (20 mg/2 mL)
|
Solution for Injection. (I.M./I.V.)
|
-
|
Sterile-Gene Life sciences (P) Ltd.
|
India
|
Initial
|
17 April 2023
|
17 April 2025
|