| View |
|
DRP-13116
|
Sitagliptin (as Phosphate)
|
Sitaglipsaph-100
|
100 mg
|
Film Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
02 December 2022
|
02 December 2027
|
| View |
|
DR-XY48509
|
Multivitamins
|
Enervon-C Filmcap
|
Formulation
Each Tablet Contains:
Ascorbic Acid (Vitamin C)
500 mg
Thiamine Mononitrate (Vitamin B1)
50 mg
Niacinamide (Vitamin B3)
50 mg
Calcium Pantothenate
20 mg
Riboflavin (Vitamin B2)
20 mg
Pyridoxine Hydrochloride (Vitamin B6)
5 mg
Cyanocobalamin (Vitamin B12)
5 mcg
|
Film-Coated Tablet
|
-
|
United International Pharma Co., Ltd.
|
India
|
Initial(OTC)
|
06 December 2022
|
06 December 2027
|
| View |
|
DRP-13100
|
Diphenhydramine Hydrochloride +
Phenylpropanolamine Hydrochloride
|
Rhinimax
|
12.5 mg/12.5 mg per 5 mL
|
Syrup
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
06 December 2022
|
06 December 2027
|
| View |
|
DRP-13099
|
Diphenhydramine Hydrochloride +
Phenylpropanolamine Hydrochloride
|
Rhinimax
|
25 mg/ 25 mg
|
Capsule
|
-
|
PT Medifarma Laboratories
|
Indonesia
|
Initial (OTC)
|
06 December 2022
|
06 December 2027
|
| View |
|
DRP-13123
|
Prednisolone (As Acetate)
|
Saphnisolone-S10
|
10mg/mL (1% w/v)
|
Ophthalmic Suspension (eye drops)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
02 December 2022
|
02 December 2027
|
| View |
|
BR-1434
|
Rotavirus Vaccine, (Live
Attenuated)
|
Rotasiil-Liquid
|
Formulation:
Each dose (2 mL) contains:
Live, Attenuated Bovine - Human Rotavirus Reassortant
[G1, G2, G3, G4, and G9]*
*Grown on Vero cells
**FFU= Focus-forming Unit
***CCID= Cell culture infectious disease
≥105.6 FFU**/serotype (NLT 6.30 log10 CCID 50*** per dose)
|
Oral Suspension
|
-
|
Serum Institute of India Private Limited
|
India
|
Monitored Release
|
28 November 2022
|
28 November 2027
|
| View |
DR-XY48517_PI_01.pdf
|
DR-XY48517
|
Tolvaptan
|
Jinarc
|
15mg
|
Tablet
|
-
|
Otsuka Factor Pharmaceutical Co., Ltd. (Tokushima Itano Factory)
|
Japan
|
Monitored Release
|
01 December 2022
|
01 December 2027
|
| View |
|
DR-XY48515
|
Oxycodone hydrochloride
|
Oxymarc
|
10 mg/mL
|
Solution for Injection/Infusion (IV/SC)
|
-
|
HBM Pharma S.R.O.
|
Slovak Republic
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
|
DRP-10440-01
|
Ceftriaxone (as sodium)
|
Gaspixone-5
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
NCPC Hebei Huamin Pharmaceutical Company
|
China
|
CLIDP Conversion
|
15 December 2022
|
08 October 2026
|
| View |
|
DRP-10512-12
|
Febuxostat
|
Febuschwartz
|
40 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd
|
India
|
CLIDP Conversion
|
15 December 2022
|
07 October 2026
|
| View |
|
DRP-9523
|
Ascorbic Acid
|
Marlum-C
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate)
|
Capsule
|
Vitamin
|
Lumar Pharmaceutical Laboratory
|
Philippines
|
Automatic Renewal
|
13 December 2022
|
01 February 2028
|
| View |
|
DRP-12037-06
|
Sitagliptin (as phosphate monohydrate) + Metformin hydrochloride
|
Strasimet
|
50 mg/1 g
|
Film-Coated Tablet
|
-
|
Sai Mirra Innopharm Pvt. Ltd.
|
India
|
CLIDP Conversion
|
15 December 2022
|
02 June 2027
|
| View |
|
DRP-12080-02
|
Nebivolol (as hydrochloride)
|
Nebigo
|
5 mg
|
Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
CLIDP Conversion
|
15 December 2022
|
09 June 2027
|
| View |
|
DRP-12412-05
|
Losartan Potassium
|
Raptrasol
|
50 mg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc
|
Philippines
|
CLIDP Conversion
|
15 December 2022
|
03 August 2025
|
| View |
|
DRP-6609-05
|
Ondansetron (as hydrochloride dihydrate)
|
Onsiatab
|
8 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd
|
India
|
CLIDP Conversion
|
14 December 2022
|
30 March 2026
|
| View |
|
DRP-7543-05
|
CEFUROXIME (AS AXETIL)
|
APPEXCEF
|
250 mg/5 mL
|
Granules for Oral Suspension
|
ANTIBACTERIAL (CEPHALOSPORINS)
|
J.M. Tolmann Laboratories Inc
|
Philippines
|
Renewal
|
24 August 2024
|
14 October 2029
|
| View |
|
DRP-10199-07
|
Trimetazidine Hydrochloride
|
Gotridine
|
35mg
|
Modified Release Tablet
|
-
|
Zim Laboratories Limited
|
India
|
CLIDP Conversion
|
14 December 2022
|
04 August 2026
|
| View |
|
DPR-9616-02
|
Telmisartan
|
None
|
40 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd
|
India
|
CLIDP Conversion
|
13 December 2022
|
25 March 2026
|
| View |
|
DRP-1140-09
|
Ceftriaxone (as sodium)
|
Cefrimed
|
1 g
|
Powder for Injection (I.M./I.V.)
|
-
|
Inject Care Parenterals Pvt. Ltd
|
India
|
CLIDP Conversion
|
13 December 2022
|
19 February 2026
|
| View |
|
DRP-1232-02
|
Atorvastatin (as calcium)
|
Avamax
|
40 mg
|
Film-Coated Tablet
|
Antihypercholesterolemia
|
Ranbaxy (M) Sdn. Bhd
|
Malaysia
|
Renewal
|
29 January 2024
|
02 February 2029
|