| View |
|
DRP-14618
|
Fexofenadine hydrochloride
|
Histafen
|
180 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
03 November 2023
|
03 November 2028
|
| View |
|
DR-XY48909
|
Apixaban
|
Axasoar 5
|
5 mg
|
Film-Coated Tablet
|
-
|
USV Private Limited
|
India
|
Initial
|
23 October 2023
|
23 October 2028
|
| View |
|
DR-XY48910
|
Apixaban
|
Axasoar 2.5
|
2.5 mg
|
Film-Coated Tablet
|
-
|
USV Private Limited
|
India
|
Initial
|
23 October 2023
|
23 October 2028
|
| View |
|
DRP-14594
|
Rivaroxaban
|
Rivazest 10
|
10 mg
|
Film-Coated Tablet
|
-
|
Cipla Limited Indore Sez (Unit IV
|
India
|
Initial
|
20 October 2023
|
20 October 2028
|
| View |
|
DRP-14571
|
Ceftriaxone (as sodium) + Sulbactam (as sodium)
|
Saphtriaxone-SB
|
1 g/500 mg
|
Powder for Injection (I.M./I/V.)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial (Re-application)
|
19 October 2023
|
19 October 2028
|
| View |
|
DRP-14597
|
Esmolol hydrochloride
|
Ermoloc
|
10 mg/mL (2.5 g/250 mL)
|
Solution for IV Infusion
|
-
|
Osel Ilac San. Ve Tic. A.S.
|
Turkey
|
Initial
|
23 October 2023
|
23 October 2028
|
| View |
|
DRP-14585
|
Telmisartan
|
Misarven 80
|
80 mg
|
Tablet
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
19 October 2023
|
19 October 2028
|
| View |
|
DRP 4614-01
|
Azithromycin (as dihydrate)
|
None
|
500 mg
|
Film-Coated Tablet
|
-
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial (Variation)
|
19 October 2023
|
06 May 2027
|
| View |
|
DRP 4829-01
|
Propranolol hydrochloride
|
None
|
10 mg
|
Film-Coated Tablet
|
-
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial (Variation)
|
19 October 2023
|
15 August 2027
|
| View |
|
DR-XY48245
|
Pregabalin + Mecobalamin
|
Preg-M
|
75 mg/750 mcg
|
Capsule
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Monitored Release (Reconstruction)
|
19 October 2023
|
29 December 2024
|
| View |
|
HRP-604
|
Petroleum Jelly
|
Saphprotek
|
965 mg/g (96.5% w/w)
|
Topical Ointment
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
12 May 2023
|
12 May 2028
|
| View |
|
DRP-13423
|
Doxorubicin Hydrochloride
|
Anthra-50
|
50 mg
|
Lyophilized Powder for Injection (I.V.)
|
-
|
Admac Lifesciences
|
India
|
Initial
|
15 February 2023
|
15 February 2028
|
| View |
|
DRP-13925
|
Mometasone furoate (as monohydrate)
|
Nasehaler
|
50 mcg per actuation (0.05% w/w)
|
Nasal Spray
Suspension
|
Corticosteroid
|
Cipla Limited, Indore Sez (Unit III)
|
India
|
Initial (Reconstruction)
|
27 May 2024
|
18 May 2028
|
| View |
|
DRP-13883
|
Mirtazapine
|
None
|
30 mg
|
Orodispersible Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
11 May 2023
|
11 May 2028
|
| View |
|
DRP-13392
|
Tamsulosin
|
Ureazy
|
400 mcg
|
Prolonged-Release Tablet
|
-
|
MAGBRO HEALTHCARE PVT. LTD.
|
India
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DRP-13238-04
|
Ursodeoxycholic Acid
|
Girsofalk
|
250 mg
|
Capsule
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
CLIDP Conversion
|
21 July 2023
|
06 January 2028
|
| View |
|
DRP-11044-03
|
Potassium Citrate
|
Kelcitra
|
1080 mg
|
Extended-Release Tablet
|
-
|
Magbro Healthcare Pvt. Ltd
|
India
|
CLIDP Conversion
|
09 July 2023
|
18 January 2027
|
| View |
|
DRP-11044-04
|
Potassium Citrate
|
Gitrate
|
1080 mg
|
Extended-Release Tablet
|
-
|
Magbro Healthcare Pvt. Ltd
|
India
|
CLIDP Conversion
|
12 July 2023
|
18 January 2027
|
| View |
|
DRP-5240-24
|
Ceftriaxone (as sodium)
|
Kcef
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Scott-Edil Advance Research Laboratories & Education Ltd.
|
India
|
Renewal
|
07 May 2024
|
07 April 2029
|
| View |
|
DRP-13714-1
|
Losartan Potassium + Hydrochlorothiazide
|
None
|
50 mg/ 12.5 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd
|
India
|
CLIDP Conversion
|
09 August 2023
|
26 April 2028
|