| View |
|
DRP-5188-01
|
Losartan Potassium
|
None
|
50 mg
|
Film-Coated Tablet
|
Angiotensin-II-Receptor Blocker
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Renewal
|
23 March 2023
|
25 October 2028
|
| View |
|
HRP-267-03
|
Povidone-Iodine
|
None
|
100 mg/mL (10% w/v)
|
Topical Solution
|
Antiseptic
|
Azarias Pharmaceutical Laboratories Inc
|
Philippines
|
Renewal
|
21 March 2023
|
08 February 2028
|
| View |
|
DRP-13559
|
Alpha Ketoanalogues + Essential Amino Acids
|
Aminoral
|
FORMULATION:
Each tablet contains:
a-Ketoisoleucine, Calcium Salt 67 mg
a-Ketoleucine, Calcium Salt 101 mg
a-Ketophenylalanine, Calcium Salt 68 mg
a-Ketovaline, Calcium Salt 86 mg
a-Hydroxymethionine, Calcium Salt 59 mg
L-Lysine Acetate 105 mg
L-Threonine 53 mg
L-Tryptophan 23 mg
L-Histidine 38 mg
L-Tyrosine 30 mg
Total calcium 50 mg
|
Film Coated Tablet
|
-
|
PT. Fresenius Kabi Combiphar
|
Indonesia
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13624
|
Acetylcysteine
|
Acteinsaph-100
|
20 mg/mL (100 mg/5 mL)
|
Syrup
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
20 March 2023
|
20 March 2028
|
| View |
|
DRP-13623
|
Acetylcysteine
|
Cysaphteine-100
|
20 mg/mL (100 mg/5 mL)
|
Syrup
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
20 March 2023
|
20 March 2028
|
| View |
|
DRP-13593
|
Zoledronic acid (as monohydrate)
|
Sorliv
|
4mg/5mL
|
Solution for Intravenous Infusion
|
-
|
Shilpa Medicare Limited, Unit. 4, Pharmaceutical Formulations SEZ
|
India
|
Initial
|
14 March 2023
|
14 March 2028
|
| View |
|
DRP-13582
|
Gabapentin
|
Novapentin
|
600 mg
|
Film Coated Tablet
|
-
|
Saga Lifesciences Limited
|
India
|
Initial
|
14 March 2023
|
14 March 2028
|
| View |
|
DRP-13563
|
Levofloxacin (as hemihydrate)
|
Starlev
|
5 mg/mL (500 mg/100 mL)
|
Solution for I.V. Infusion
|
-
|
Indus Pharma (Pvt.) Ltd.
|
Pakistan
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13554
|
Rabeprazole Sodium
|
Maribezole
|
20 mg
|
Enteric Coated Tablet
|
-
|
Akums Drugs & Pharmaceuticals Ltd. (Plant I - Solid
Oral Dosage Facility)
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13555
|
Rabeprazole Sodium
|
Raingra
|
20 mg
|
Enteric Coated Tablet
|
-
|
Akums Drugs & Pharmaceuticals Ltd. (Plant I - Solid
Oral Dosage Facility)
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13595
|
Propofol
|
Novafrol
|
10 mg/mL (1% w/v)
|
Emulsion for Intravenous Injection
|
-
|
Dongkook Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
15 March 2023
|
15 March 2028
|
| View |
|
DRP-13581
|
Betametasone (as valerate) + Clotrimazole + Gentamicin (as sulfate)
|
Bezogen
|
500 mcg/10 mg/1 mg per g (0.05%/1%/0.1% w/w)
|
Topical Ointment
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
14 March 2023
|
14 March 2028
|
| View |
|
DRP-13566
|
Parecoxib (as sodium)
|
Coximed
|
40mg
|
Lyophilized Powder for Injection (IM/IV)
|
-
|
Wanbang Biopharmaceuticals
|
China
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13586
|
Moxifloxacin (as Hydrochloride) + Dexamethasone
Phosphate (as Sodium)
|
Opthomox DX
|
5 mg/1 mg per mL (0.5% w/v/ 0.1% w/v)
|
Sterile Ophthalmic Solution
|
-
|
Indiana Ophthalmics
|
India
|
Initial
|
14 March 2023
|
14 March 2028
|
| View |
|
DRP-13610
|
Sevelamer (as Carbonate)
|
Selaglob 800
|
800mg
|
Film Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
16 March 2023
|
16 March 2028
|
| View |
|
DRP-13560
|
Metformin Hydrochloride
|
Metfn
|
500mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13556
|
Losartan (as Potassium)
|
Losarx 50
|
50mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13557
|
Losartan (as Potassium)
|
Losarx 100
|
100mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DRP-13612
|
Etoricoxib
|
Etozox
|
60 mg
|
Film Coated Tablet
|
-
|
Cipla Ltd.
|
India
|
Initial
|
16 March 2023
|
16 March 2028
|
| View |
|
DR-XY48656
|
Aripiprazole
|
Aripraz 5
|
5 mg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
16 March 2023
|
16 March 2028
|