| View |
|
DR-XY48915
|
Cefuroxime (as sodium)
|
Shamcef-1500
|
1.5 g
|
Powder for Injection (IM/IV)
|
-
|
Shamshree Lifesciences Ltd.
|
India
|
Initial
|
09 November 2023
|
09 November 2028
|
| View |
|
DR-XY48916
|
Cefuroxime (as sodium)
|
Shamcef-750
|
750 mg
|
Powder for Injection (I.V.)
|
-
|
Shamshree Lifesciences Ltd.
|
India
|
Initial
|
09 November 2023
|
09 November 2028
|
| View |
|
DR-XY48949
|
Ceftriaxone (as sodium)
|
None
|
1 g
|
Powder for Injection (IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
DR-XY48913
|
Benzydamine hydrochloride + Cetylpyridinium chloride
|
Orawell
|
1.5 mg/5 mg
|
Oromucosal Spray Solution
|
Non-steroidal anti-inflammatory/Antiseptic
|
KRKA, D.D., Novo Mesto
|
Slovenia
|
Monitored Release (Correction)
|
09 May 2024
|
07 November 2028
|
| View |
|
DR-XY48810
|
Cabazitaxel
|
Cabxel
|
60 mg/1.5 mL
|
Concentrate for Solution for IV Infusion
|
-
|
Hetero Labs Limited (Unit-VI)
|
India
|
Initial
|
12 July 2023
|
12 July 2028
|
| View |
|
DRP-14168
|
Digoxin
|
Saphnoxin
|
250 mcg/mL (500 mcg/2 mL)
|
Solution For Injection
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
18 July 2023
|
18 July 2028
|
| View |
|
DRP-14169
|
Docetaxel With Solvent
|
Fin-Cedo 80
|
20 mg/0.5 mL (80 mg/2 mL)
|
Concentrate Solution for IV
Infusion
|
-
|
VENUS REMEDIES , LIMITED
|
India
|
Initial
|
12 July 2023
|
12 July 2028
|
| View |
|
DRP-14651
|
Ceftriaxone (as sodium)
|
Fin-Cef 1
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Venus Remedies Limited
|
India
|
Initial
|
16 November 2023
|
16 November 2028
|
| View |
|
DRP-14693
|
Rosuvastatin (as calcium)
|
Rozusan-10
|
10 mg
|
Film-Coated Tablet
|
-
|
Gracure Pharmaceutical Ltd.
|
India
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
|
DRP-14694
|
Rosuvastatin (as calcium)
|
Rozusan-20
|
20 mg
|
Film-Coated Tablet
|
-
|
Gracure Pharmaceutical Ltd.
|
India
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
|
BR-1456
|
Insulin Aspart
|
Kirsty
|
100 Units/mL (equivalent to 3.5 mg/mL)
|
Solution for Injection (SC)
|
-
|
Biocon Sdn BHD
|
Malaysia
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
|
BR-1457
|
Insulin Aspart
|
Kirsty
|
100 Units/mL (equivalent to 3.5 mg/mL)
|
Solution for Injection (SC)
|
-
|
Biocon Sdn BHD
|
Malaysia
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
|
DR-XY48918
|
Tegafur Gimeracil Oteracil potassium
|
S-1 20
|
20 mg/5.8 mg/19.6 mg
|
Capsule
|
-
|
Taiho Pharmaceutical Co., Ltd.
|
Japan
|
Monitored Release
|
15 November 2023
|
15 November 2028
|
| View |
|
DRP-14177
|
Ketoconazole
|
Porazole
|
20mg/g (2% w/w)
|
Cream
|
-
|
Kwality Pharmaceutical Ltd.
|
India
|
Initial
|
14 July 2023
|
14 July 2028
|
| View |
|
DRP-14649
|
Cloxacillin (as sodium)
|
Cloxamed 1000
|
1 g
|
Powder for Injection (I.M./I.V.)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
15 November 2023
|
15 November 2028
|
| View |
|
DR-XY48936
|
Doripenem (as monohydrate)
|
None
|
500 mg
|
Powder for Injection (I.V.)
|
-
|
Shamshree Lifesciences Ltd.
|
India
|
Initial
|
29 November 2023
|
29 November 2028
|
| View |
|
DRP-14176
|
Phenytoin Sodium
|
Haizure
|
50mg/mL
BATCH SIZE
|
Solution For Injection
|
-
|
SWISS PARENTERALS LTD.
|
India
|
Initial
|
14 July 2023
|
14 July 2028
|
| View |
|
DR-XY48917
|
Tegafur Gimeracil + Oteracil potassium
|
S-1 25
|
25 mg/7.25 mg/24.5 mg
|
Capsule
|
-
|
Taiho Pharmaceutical Co., Ltd.
|
Japan
|
Monitored Release
|
15 November 2023
|
15 November 2028
|
| View |
|
DRP-14647
|
Ascorbic Acid
|
None
|
500 mg
|
Film Coated Tablet
|
-
|
Medisure Laboratories Pakistan (Pvt) Limited
|
Pakistan
|
Initial
|
14 November 2023
|
14 November 2028
|
| View |
|
DRP-14178
|
Rifampicin + Isoniazid + Pyrazinamide + Ethambutol
|
Rimstar 4
|
150mg+75mg+400mg+275mg
|
Film-Coated Tablet
|
-
|
Panacea Biotec Limited
|
India
|
Initial
|
14 July 2023
|
14 July 2028
|