| View |
|
DRP-14811
|
Racecadotril
|
None
|
10 mg
|
Granules For Oral Suspension
|
-
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Initial
|
12 January 2024
|
12 January 2029
|
| View |
|
DRP-14810
|
Racecadotril
|
None
|
30 mg
|
Granules For Oral Suspension
|
-
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Initial
|
12 January 2024
|
12 January 2029
|
| View |
|
DRP-14793
|
Quetiapine (as fumarate)
|
Pinarox
|
200mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
12 January 2024
|
12 January 2029
|
| View |
|
DRP-14792
|
Quetiapine (as fumarate)
|
Pinarox
|
300mg
|
Film-Coated Tablet
|
Antipsychotic
|
Globela Pharma Private Limited
|
India
|
Initial
|
12 January 2024
|
12 January 2029
|
| View |
|
DRP-14794
|
Quetiapine (as fumarate)
|
Pinarox
|
100mg
|
Film-Coated Tablet
|
Antipsychotic
|
Globela Pharma Private Limited
|
India
|
Initial
|
12 January 2024
|
12 January 2029
|
| View |
|
DRP-14795
|
Quetiapine (as fumarate)
|
Pinarox
|
25mg
|
Film-Coated Tablet
|
Antipsychotic
|
Globela Pharma Private Limited
|
India
|
Initial
|
12 January 2024
|
12 January 2029
|
| View |
|
DRP-14816
|
Ciprofloxacin
|
Acucip
|
2 mg/mL
|
Solution For IV Infusion
|
Antibacterial (Fluoroquinolone)
|
Aculife Healthcare Private Limited
|
India
|
Initial
|
15 January 2024
|
15 January 2029
|
| View |
|
DRP-14815
|
Cefuroxime (as sodium)
|
Xinalat
|
750 mg
|
Powder For Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
15 January 2024
|
15 January 2029
|
| View |
|
DR-XY48977
|
Chloramphenicol (as sodium succinate)
|
Chlorbact 1gm
|
1 g
|
Powder For Injection (Iv)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
15 January 2024
|
15 January 2029
|
| View |
|
DRP-14814
|
Ceftriaxone (as sodium)
|
Hantox
|
1 g
|
Powder for Injection (IV)
|
-
|
Hansel Pharmaceuticals (Pvt.)
|
Pakistan
|
Initial
|
15 January 2024
|
15 January 2029
|
| View |
|
DRHR-2324
|
Methyl Salicylate + Camphor + Menthol
|
None
|
20 mg/10 mg/5 mg per mL
|
Liniment (Lavender Scent)
|
-
|
Greenstone Pharmaceutical Inc.
|
Philippines
|
Initial
|
16 January 2024
|
16 January 2029
|
| View |
|
BR-1464
|
Trastuzumab deruxtecan
|
Enhertu
|
100 mg
|
Powder for Concentrate for Solution for Infusion (IV)
|
Human Epidermal Growth Factor Receptor 2 (HER2)
Inhibitor
|
Baxter Oncology GmbH
|
Germany
|
Monitored Release
|
15 January 2024
|
15 January 2029
|
| View |
|
DRP-10144
|
Telmisartan + Amlodipine (as besilate)
|
Twinact
|
40 mg 5 mg
|
Tablet
|
-
|
Dasan Pharmaceutical Co., Ltd.
|
Korea
|
Initial (Reconstruction)
|
16 January 2024
|
30 July 2026
|
| View |
|
DRP-10987
|
Furosemide
|
Aefur
|
10 mg/mL (20 mg/2mL)
|
Solution for Injection (I.M./I.V.)
|
-
|
Sui Guan Chem, Ind. Co., Ltd.
|
Taiwan
|
Initial (Reconstruction)
|
16 January 2024
|
28 January 2026
|
| View |
|
DRP-3836-03
|
Betahistine hydrochloride
|
Allerway
|
16 mg
|
Film-Coated Tablet
|
-
|
J.M. Tolmann Laboratories Inc.
|
Philippines
|
Automatic Renewal
|
15 January 2024
|
09 December 2025
|
| View |
DR-XY48744_PI_01.pdf
|
DR-XY48744
|
Labetalol Hydrochloride
|
Betalex
|
5 mg/mL (20 mg/4 mL)
|
Solution for Injection (IV)
|
-
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
25 May 2023
|
25 May 2028
|
| View |
|
DR-XY13019
|
Morphine Sulfate
|
MST CONTINUS
|
30 mg
|
Modified-Release Tablet
|
-
|
Bard Pharmaceuticals Limited
|
United Kingdom
|
Automatic Renewal
|
25 September 2020
|
17 July 2025
|
| View |
|
DRP-11849-01
|
Dutasteride + Tamsulosin Hydrochloride
|
Tamduet
|
500 mcg/ 400 mcg
|
Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd
|
India
|
CLIDP Conversion
|
08 May 2023
|
10 May 2027
|
| View |
|
DRP-13352-01
|
Apixaban
|
Xavi
|
2.5 mg
|
Film Coated Tablet
|
-
|
Natco Pharma Limited (Unit IV and V)
|
India
|
CLIDP Conversion
|
10 April 2023
|
02 February 2028
|
| View |
|
DRP-14824
|
Meclizine hydrochloride
|
None
|
12.5 mg
|
Chewable Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial [OTC]
|
17 January 2024
|
17 January 2029
|