| View |
|
DRP-7133-02
|
Metoprolol Tartrate
|
None
|
50 mg
|
Film-Coated Tablet
|
Beta-Blocking Agent
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (CLIDP (Correction)
|
26 November 2021
|
13 April 2025
|
| View |
|
DRP-4474-14
|
Ceftriaxone (As Sodium)
|
New Ambiceph
|
1 g
|
Powder For Injection (I.M/I.V.)
|
Antibacterial (Cephalosporin)
|
Brawn Laboratories Ltd.
|
India
|
Automatic Renewal
|
11 October 2022
|
13 June 2028
|
| View |
|
DR-XY47565
|
Fluconazole
|
None
|
2 mg/mL (100 mg/50 mL, 200 mg/100 mL, and 400 mg/200 mL)
|
Solution for Intravenous Infusion
|
-
|
B. Braun Medical, SA
|
Spain
|
-
|
29 November 2021
|
29 November 2026
|
| View |
|
DR-XY47497
|
Adapalene
|
Adana
|
1 mg/g (0.1% w/w)
|
Topical Gel
|
-
|
Rhydburg Pharmaceutical Limited
|
India
|
-
|
29 November 2021
|
29 November 2026
|
| View |
|
DR-XY47570
|
Cefuroxime (as Sodium)
|
Texim
|
750 mg
|
Powder for Injection (I.M./I.V.)
|
-
|
Theon Pharmaceuticals Limited
|
India
|
-
|
29 November 2021
|
29 November 2026
|
| View |
|
DRP-10827
|
Thiamine Hydrochloride + Pyridoxine Hydrochloride +
Cyanocobalamin
|
Enplex-B
|
100 mg/100 mg/1 mg per 3 mL
|
Solution for Injection (I.M.)
|
Vitamins
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
01 December 2021
|
01 December 2026
|
| View |
DR-XY47574_PI_01.pdf
|
DR-XY47574
|
Cilnidipine
|
Cildine
|
10mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
india
|
-
|
01 December 2021
|
01 December 2026
|
| View |
DR-XY47575_PI_01.pdf
|
DR-XY47575
|
Cilnidipine
|
Cildine
|
20mg
|
Film-Coated Tablet
|
Calcium Channel Blocker (Dihydropyridine Derivative)
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
01 December 2021
|
01 December 2026
|
| View |
|
DRHR-2103
|
Eucalyptus + Menthol + Methyl Salicylate
|
None
|
202.5mg/24.4mg/5.1 mg per mL
|
Solution
Inhalation
|
-
|
Felton Grimwade & Bosisto's Pty Ltd
|
Australia
|
-
|
25 November 2021
|
25 November 2025
|
| View |
DRP-10828_PI_01.pdf
|
DRP-10828
|
Ledipasvir + Sofosbuvir
|
Lisof
|
90mg/400mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit V and Unit V-A)
|
India
|
-
|
01 December 2021
|
01 December 2026
|
| View |
|
DR-XY47571
|
Trimetazidine hydrochloride
|
Terazidine
|
35mg
|
Modified Release Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial (Correction)
|
20 May 2022
|
29 November 2026
|
| View |
|
DR-XY47566
|
Acetylcysteine
|
None
|
100 mg
|
Granules For Oral Suspension
|
-
|
Northfield Laboratories, Inc.
|
Philippines
|
-
|
29 November 2021
|
29 November 2026
|
| View |
|
DR-XY47561
|
Ketotifen (As Fumarate)
|
Allernil
|
250 mcg/mL (0.025% w/v)
|
Ophthalmic Solution (Eye
Drops)
|
-
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
Initial (Re-issuance)
|
12 August 2022
|
23 November 2026
|
| View |
|
HMR-100
|
Vitex Negundo L. (Lagundi Leaf)
|
Ofplemed Forte
|
600 mg
|
Capsule
|
Herbal Medicine (Anti-Cough/Anti-asthma)
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Automatic Renewal
|
09 February 2023
|
11 April 2028
|
| View |
|
DRP-5421-06
|
Telmisartan
|
Telmidis-40
|
40 mg
|
Tablet
|
Angiotensin II Receptor Blocker
|
Healer's Lab (Unit II)
|
India
|
Renewal
|
25 July 2024
|
05 August 2029
|
| View |
|
DRP-10824
|
Carvedilol
|
None
|
12.5 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
29 November 2021
|
29 November 2026
|
| View |
|
DRP-10818
|
Salmeterol (as xinafoate) + Fluticasone propionate
|
Flutixin 500
|
50 mcg/500 mcg
|
Dry Powder for Inhalation in Capsule
|
Selective Beta-2-adrenoreceptor agonist/Corticosteroid
|
Mepro Pharmaceuticals Private Limited
|
India
|
Initial
|
29 November 2021
|
29 November 2026
|
| View |
|
DRP-10801
|
Sodium bicarbonate
|
Sobinate
|
84 mg/mL (8.4% w/v)
|
Solution for Injection
(I.V. Infusion)
|
Electrolyte Replenisher / Systemic Alkalinising Agent
|
BC World Pharm. Co., Ltd.
|
Korea
|
Initial (Reconstruction)
|
13 March 2024
|
21 December 2026
|
| View |
|
DRHR-2105
|
Menthol + Methyl Salicylate + Camphor + Borneol +
Thymol + Zinc Oxide
|
SK Pas
|
74.41 mg/64.41 mg/32.01 mg/2.45mg/1.58 mg/35.18mg
|
Plaster
|
-
|
Zhejiang Bangli Medical Products Co., Ltd.
|
China
|
-
|
25 November 2021
|
25 November 2026
|
| View |
|
DRHR-2104
|
Menthol + Methyl Salicylate + Camphor + Borneol +
Thymol + Zinc Oxide
|
SK Pas
|
166.53mg/137.46mg/71.66mg/5.50mg/3.53 mg/78.73mg
|
Plaster
|
Counterirritant
|
Zhejiang Bangli Medical Products Co., Ltd.
|
China
|
Initial [HR]
|
25 November 2021
|
25 November 2026
|