| View |
|
DRP-11285
|
Imatinib (As Mesilate)
|
Imatero 100
|
100mg
|
Film-Coated Tablet
|
Antineoplastic (Protein-Tyrosine Kinase Inhibitor)
|
Hetero Labs Limited (Unit-VI)
|
India
|
Initial
|
22 February 2022
|
22 February 2027
|
| View |
|
DRP-11284
|
Imatinib (As Mesilate)
|
Imatero 400
|
400 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit-VI)
|
India
|
-
|
22 February 2022
|
22 February 2027
|
| View |
|
DRP-11267
|
Cetirizine
|
None
|
5 mg/5 mL
|
Syrup
|
-
|
Rhydburg Pharmaceuticals Limited
|
India
|
Initial
|
21 February 2022
|
21 February 2027
|
| View |
|
DR-XY47736
|
Zoledronic acid (as monohydrate)
|
Myzole
|
4 mg/5 mL
|
Concentrate Solution for IV Infusion
|
Biphosphanates
|
Mylan Laboratories Limited (Specialty Formulation
Facility)
|
India
|
Initial
|
22 February 2022
|
22 February 2027
|
| View |
|
DR-XY47735
|
Omidenepag Isopropyl
|
Eybelis
|
20 mcg/mL (0.002% w/v)
|
Sterile Ophthalmic Solution
|
-
|
Santen Pharmaceutical Co., Ltd. (Shiga Plant)
|
Japan
|
-
|
22 February 2022
|
22 February 2025
|
| View |
|
DR-XY47749
|
Epirubicin Hydrochloride
|
Epribenz-50
|
50mg
|
Lyophilized Powder for Injection (IV/Intravesical)
|
Antineoplastic Agent
|
ADMAC Lifesciences
|
India
|
Initial
|
23 February 2022
|
23 February 2027
|
| View |
|
DR-XY47750
|
Epirubicin Hydrochloride
|
Epribenz-10
|
10mg
|
Lyophilized Powder for Injection (IV/Intravesical)
|
Antineoplastic Agent
|
ADMAC Lifesciences
|
India
|
Initial
|
23 February 2022
|
23 February 2027
|
| View |
|
DRP-11260
|
Enzalutamide
|
Bdenza
|
40 mg
|
Capsule
|
Anti-androgen (Androgen Receptor Antagonist)
|
BDR Pharmaceuticals International Pvt. Ltd.
|
India
|
Initial
|
18 February 2022
|
18 February 2027
|
| View |
|
DR-XY47758
|
Tirofiban (as hydrochloride monohydrate)
|
Aggrastat
|
250 mcg/mL
|
Concentrate Solution for IV Infusion
|
Platelet Aggregation Inibitor
|
Siegfried Hameln GmbH
|
Germany
|
Initial
|
24 February 2022
|
24 February 2027
|
| View |
|
DRP-11266
|
Metoclopramide Hydrochloride
|
Metoclon
|
5 mg/mL (10 mg/2 mL)
|
Solution for Injection
(IM/IV)
|
Propulsive
|
Indus Pharma (Pvt.) Ltd.
|
Pakistan
|
Initial
|
21 February 2022
|
21 February 2027
|
| View |
|
DRP-11261
|
Gefitinib
|
Blitinib
|
250 mg
|
Film-Coated Tablet
|
Antineoplastic
|
Jodas Expoim Pvt. Ltd.
|
India
|
Automatic Renewal (Correction)
|
25 October 2023
|
22 February 2027
|
| View |
|
DRHR-2126
|
Ethyl Alcohol
|
Doctor J
|
70% (v/v)
|
Solution
|
Antiseptic/Disinfectant
|
Kohl Industries Corporation
|
Philippines
|
Initial
|
21 February 2022
|
21 February 2025
|
| View |
|
DRP-11245
|
Co-Amoxiclav (see reverse for formulation)
|
Elmox-CV 312.5
|
312.5 mg per 5 mL
|
Powder for Oral Suspension
|
Antibacterial (Penicillin/Beta-lactamase inhibitor)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
21 February 2022
|
21 February 2027
|
| View |
|
BR-545
|
Epoetin Alfa
|
Wepox 4000
|
4,000 IU/mL
|
Solution for Injection (IV/SC)
|
Antianemic Preparations
|
Wockhardt Ltd.
|
India
|
Initial
|
21 February 2022
|
21 April 2025
|
| View |
|
DRP-11251
|
Levocetirizine Dihydrochloride
|
Novacetrin
|
5 mg
|
Film-Coated Tablet
|
-
|
Acme Formulation Pvt. Ltd.
|
India
|
Initial
|
17 February 2022
|
17 February 2027
|
| View |
|
DRHR-2127
|
Isopropyl Alcohol
|
Alcoplus
|
70% (v/v)
|
Topical Solution
|
Antiseptic/Disinfectant
|
Ocean Deep Industries
|
Philippines
|
Initial
|
21 February 2022
|
21 February 2027
|
| View |
|
DRP-11156
|
Tramadol hydrochloride + Paracetamol
|
Standol
|
37.5 mg/325 mg
|
Film-Coated Tablet
|
Opioid and Non-Opioid Analgesic Combination
|
Standard Chem & Pharm. Co., Ltd.
|
Taiwan
|
Initial
|
22 February 2022
|
22 February 2027
|
| View |
|
DRP-11246
|
Hydralazine Hydrochloride
|
Sapharin
|
20 mg/mL
|
Solution for Injection (IM/IV)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
-
|
21 February 2022
|
21 February 2027
|
| View |
DR-XY47742_PI_01.pdf
|
DR-XY47742
|
Abemaciclib
|
Yulareb
|
50 mg
|
Film-Coated Tablet
|
-
|
Lilly del Caribe, Inc.
|
U.S.A
|
Monitored Release
|
22 February 2022
|
22 February 2027
|
| View |
DR-XY47743_PI_01.pdf
|
DR-XY47743
|
Abemaciclib
|
Yulareb
|
100 mg
|
Film-Coated Tablet
|
-
|
Lilly del Caribe, Inc.
|
U.S.A
|
Monitored Release
|
22 February 2022
|
22 February 2027
|