| View |
|
DRP-12912
|
Haloperidol
|
Hadoral
|
5 mg/mL
|
Solution For Injection (IM)
|
Antipsychotic (Butyrophenone Derivative)
|
Hiral Labs Limited
|
India
|
Initial
|
27 October 2022
|
27 October 2027
|
| View |
|
DRP-12891
|
Acetylcysteine
|
None
|
100 mg
|
Powder for Oral Solution
|
Mucolytic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
DRP-12914
|
Dapagliflozin
|
Daptica 10
|
10 mg
|
Film-Coated Tablet
|
-
|
Glenmark Pharmaceuticals Limited
|
India
|
Initial
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48442
|
Leflunomide
|
Lefno
|
20 mg
|
Film-Coated Tablet
|
Immunosuppresant
|
Kusum Healthcare Pvt. Ltd
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY26134
|
Fludarabine Phosphate
|
Fludara
|
50mg
|
Powder For Injection (IV)
|
-
|
Baxter Oncology GmbH
|
Germany
|
Initial (from Monitored Release)
|
26 October 2022
|
05 May 2025
|
| View |
|
DR-XY48447
|
Cimicifuga racemosa L. (Black Cohosh) Rhizome
|
Remifemin
|
2.5mg
|
Tablet
|
Non-Hormonal Gynecologic Phytomedicine
|
Schaper & Brümmer GmbH & Co. KG
|
Germany
|
Initial (OTC)
|
28 October 2022
|
28 October 2027
|
| View |
|
DRP-12922
|
Pemetrexed (as disodium)
|
Trepexed-500
|
500mg
|
Lyophilized Powder for IV Infusion
|
Anti-neoplastic (Folic acid analogue)
|
Admac Lifesciences
|
India
|
Initial
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48441
|
Simvastatin + Ezetimibe
|
Stadavas Plus
|
80 mg/ 10 mg
|
Tablet
|
Lipid Modifying Agents
|
Watson Pharma Pvt. Ltd.
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
|
DRP-12923
|
Risperidone
|
Sizodon 2
|
2 mg
|
Film-Coated Tablet
|
Antipsychotic
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
28 October 2022
|
28 October 2027
|
| View |
|
DRP-12921
|
Co-Amoxiclav
|
Moxinova CV
|
312.5 mg/5 mL
|
Powder for Oral Suspension (Orange Flavor)
|
Antibacterial (Penicillin + Beta-Lactamase Inhibitor)
|
Yeluri Formulations Pvt Ltd.
|
India
|
Initial (Variation)
|
21 March 2024
|
21 March 2029
|
| View |
|
DRP-12930
|
Co-Amoxiclav
|
Moxinova CV
|
375mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin + Beta-Lactamase Inhibitor)
|
Yeluri Formulations Pvt Ltd.
|
India
|
Initial
|
03 November 2022
|
03 November 2027
|
| View |
|
DRP-12898
|
Tenofovir Disoproxil Fumarate
|
Hofovir
|
300mg
|
Film Coated Tablet
|
White, opaque HDPE bottle with white opaque
polypropylene (PP) child resistant cap x 30's (Box of 1 bottle x 30 tablets)
|
Chia Tai-Tianqing Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
27 October 2022
|
27 October 2027
|
| View |
|
DRP-12929
|
Tramadol Hydrochloride
|
Saphtram
|
50 mg/mL (100mg/2mL)
|
Solution For Injection (IM/IV)
|
Opiod Analgesic
|
Kilitch Drugs (1) Ltd.
|
India
|
Initial
|
03 November 2022
|
03 November 2027
|
| View |
DR-XY48445_PI_01.pdf
|
DR-XY48445
|
Lurasidone (as Hydrochloride)
|
Lurata 80
|
80mg
|
Film-Coated Tablet
|
Antipsychotic
|
MSN Laboratories Private Limited
(Formulations Division)
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
DR-XY48443_PI_01.pdf
|
DR-XY48443
|
Tioconazole + Tinidazole + Lidocaine
|
Neopenmax XL
|
300 mg/ 200 mg/ 100 mg
|
Vaginal Suppository
|
Antibacterial (Imidazole)/ Antifungal/ Local Anesthetic
|
Exeltis İlaç San. Ve Tic. A.Ş.
|
Turkey
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48436
|
Gemcitabine (as hydrochloride)
|
Infusmart
|
10 mg/mL
|
Solution for Injection for I. V. Infusion (Ready-to-Infuse)
|
Antineoplastic Agent (Pyrimidine Analogue)
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (MR) (Reconstruction)
|
24 May 2024
|
27 October 2027
|
| View |
|
DRP-12887
|
Cefixime
|
Ultraxime
|
100 mg/5 mL
|
Granules For Suspension (Strawberry Flavor)
|
Antibacterial (Cephalosporin)
|
Asian Antibiotics, Inc.
|
Philippines
|
Initial (Variation)
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-12899
|
Pregabalin
|
Neufar 75
|
75 mg
|
Capsule
|
Antiepileptic
|
PT. Pratapa Nirmala
|
Indonesia
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
DRP-12830
|
Pregabalin
|
Neufar 150
|
150 mg
|
Capsule
|
Antiepileptic
|
PT. Pratapa Nirmala
|
Indonesia
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
DRP-12808
|
Amlodipine (As Besilate) + Hydrochlorothiazide
|
Lodipex HCTZ
|
5mg/12.5mg
|
Tablet
|
Calcium channel blocker and Diuretic
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
28 October 2022
|
28 October 2027
|