| View |
|
DRP-13145
|
Irinotecan (as hydrochloride)
|
Irnizet 40
|
20 mg/mL (40 mg/ 2 mL)
|
Concentrate Solution for I.V.
Infusion
|
Antineoplastic
|
Eugia Pharma Specialties Limited
|
India
|
Initial (Correction)
|
10 July 2024
|
07 December 2027
|
| View |
|
DRP-13148
|
Cefuroxime (as Sodium)
|
Cefusaph-1500
|
1.5 g
|
Powder For Injection (I.M./I.V.)
|
-
|
Kilitch Drugs (India) Ltd.
|
|
Initial (Correction)
|
23 March 2023
|
07 December 2027
|
| View |
|
DRP-13147
|
Cefotaxime
|
Cefotaxsaph
|
1 g
|
Powder for Solution for Injection (I.M./I.V.)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial (Correction)
|
18 January 2023
|
07 December 2027
|
| View |
|
DRP-13183
|
Cisplatin
|
Medplatin
|
500 mcg/mL (10 mg/20 mL)
|
Solution for IV Infusion
|
-
|
Venus Remedies, Limited
|
India
|
Initial
|
16 December 2022
|
16 December 2027
|
| View |
|
DRP-13185
|
Etoposide
|
Etosaphside
|
20 mg/mL (50 mg/2.5 mL, 100 mg/5 mL and 200
mg/10 mL)
|
Solution For I.V Injection
|
Antineoplastic (Podophyllotoxin Derivative)
|
Bruck Pharma Private Limited
|
India
|
Initial
|
22 December 2022
|
22 December 2027
|
| View |
|
DR-XY48498
|
Cetrorelix (as Acetate)
|
Asporelix
|
250mcg
|
Lyophilized Powder For Injection (SC)
|
-
|
Bharat Serums and Vaccines Limited
|
India
|
Initial
|
16 December 2022
|
16 December 2027
|
| View |
|
DR-XY48524
|
Telmisartan
|
None
|
80 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
09 December 2022
|
09 December 2027
|
| View |
|
DRP-13139
|
Methyldopa
|
Mydopa
|
250 mg
|
Film-Coated Tablet
|
-
|
S Kant Healthcare Limited
|
India
|
Initial
|
09 December 2022
|
09 December 2027
|
| View |
|
DRHR-2172
|
Povidone-Iodine
|
Difflam Gargle
|
10 mg/mL (1% w/v)
|
Oral Solution
(Fresh Mint Flavor)
|
-
|
Ensign Laboratories Pty. Ltd.
|
Australia
|
Initial (HR)
|
06 December 2022
|
06 December 2027
|
| View |
|
DR-XY48530
|
Sitagliptin (as phosphate monohydrate)
|
Sitavia 50
|
50 mg
|
Film-Coated Tablet
|
-
|
Korea United Pharm., Int'l Jsc.
|
Vietnam
|
Initial
|
14 December 2022
|
14 December 2027
|
| View |
|
DR-XY48531
|
Sitagliptin (as phosphate monohydrate)
|
Sitavia 100
|
100 mg
|
Film-Coated Tablet
|
-
|
Korea United Pharm., Int'l Jsc.
|
Vietnam
|
Initial
|
14 December 2022
|
14 December 2027
|
| View |
DRP-13157_PI_01.pdf
|
DRP-13157
|
Levothyroxine sodium
|
Thyres 50
|
50 mcg
|
Tablet
|
-
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
12 December 2022
|
12 December 2027
|
| View |
|
DRP-13190
|
Amlodipine (As Besilate)
|
Ampress
|
5 mg
|
Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
16 December 2022
|
16 December 2027
|
| View |
DRP-13159_PI_01.pdf
|
DRP-13159
|
Amiodarone Hydrochloride
|
Amiodal
|
50 mg/mL (150 mg/ 3 mL)
|
Sterile Concentrate Solution
for IV Infusion
|
-
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Initial (correction)
|
26 January 2023
|
12 December 2027
|
| View |
|
DR-XY48525
|
Vancomycin (As Hydrochloride)
|
Vancomarc
|
1g
|
Powder For I.V. Infusion
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
12 December 2022
|
12 December 2027
|
| View |
|
DRP-13189
|
Esomeprazole(As Magnesium Trihydrate)
|
Prazad
|
40 mg
|
Enteric-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
16 December 2022
|
16 December 2027
|
| View |
|
DRP-13143
|
Vildagliptin
|
Novaglip
|
50mg
|
Tablet
|
-
|
Unison Pharmaceuticals Pvt. Ltd. (Unit 1)
|
India
|
Initial
|
07 December 2022
|
07 December 2027
|
| View |
|
DR-XY48508
|
Multivitamins + Zinc
|
ImmunACE Plus
|
Formulation
Each Softgel Capsule Contains:
Retinol Palmitate (Vitamin A) -3,000 IU
Ascorbic Acid (Vitamin C)-500 mg
Dl-a-Tocopheryl Acetate-100 IU
Pyridoxine Hydrochloride (Vitamin B6)-1.95 mg Zinc -25 mg
|
Softgel Capsule
|
-
|
Phil Inter Pharma Co., Ltd. (Plant 1)
|
Vietnam
|
Initial (OTC)
|
28 December 2022
|
28 December 2027
|
| View |
DR-XY48536_PI_01.pdf
|
DR-XY48536
|
Fosaprepitant (as Dimeglumine)
|
Fosap
|
150 mg
|
Lyophilized Powder for Solution for IV Infusion
|
-
|
Aspiro Pharma Limited
|
India
|
Monitored Release (Correction)
|
02 February 2023
|
22 December 2027
|
| View |
|
DRP-13132
|
Carbocisteine + Zinc
|
MucoZisteine
|
500 mg/5 mg
|
Capsule
|
-
|
Compact Pharmaceuticals, Corp.
|
Philippines
|
Initial (HR)
|
13 December 2022
|
13 December 2027
|