| View |
|
DRP-15218
|
Tramadol Hydrochloride.
|
None
|
50 mg/mL
|
Solution for Injection (IM/IV)
|
Opioid Analgesic
|
Rusan Pharma Limited
|
India
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DRP-15120
|
Iron (as Iron Sucrose)
|
IroGo
|
20 mg/mL
|
Solution for Injection (IV)
|
Anti-anemia
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Initial
|
29 May 2024
|
29 May 2026
|
| View |
|
DRP-15241
|
Dacarbazine
|
Oncodac
|
200 mg
|
Lyophilized Powder for Solution for IV Infusion.
|
Antineoplastic (alkylating agent)
|
VHB Medi Sciences Limited
|
India
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DRP-15214
|
Fluconazole
|
Mycozole
|
2 mg/mL (200 mg/100 mL)
|
Solution for Intravenous Infusion
|
Antifungal
|
Taiwan Biotech Co., Ltd.
|
Taiwan
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DRP-15213
|
Oseltamivir (as phosphate)
|
Oselow 75
|
75mg
|
Capsule
|
Antiviral
|
MSN Laboratories Private Limited (Formulations Division)
|
India
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DRP-15223
|
Docetaxel (as trihydrate)
|
Maxtaxel-20
|
20 mg/0.5 mL
|
Concentrate Solution for Injection. (IV Infusion)
|
Antineoplastic Agent (Taxane)
|
United Biotech Pvt. Limited.
|
India
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DRP-15222
|
Docetaxel (as trihydrate)
|
Maxtaxel-80
|
80 mg/2 mL
|
Concentrate Solution for Injection
|
Antineoplastic Agent (Taxane)
|
United Biotech Pvt. Limited
|
India
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DR-XY49098
|
Cetirizine hydrochloride
|
Benadryl One
|
10 mg
|
Film-Coated Tablet
|
Antihistamine (Piperazine Derivative)
|
Janssen-Cilag S.P.A.
|
Italy
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DR-XY49097
|
Cetirizine hydrochloride
|
Benadryl One
|
10 mg
|
Film-Coated Tablet
|
Antihistamine (Piperazine Derivative)
|
Janssen-Cilag S.P.A
|
Italy
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DRP-15215
|
Bicalutamide
|
Lutaprost
|
50 mg
|
Film-Coated Tablet
|
Antineoplastic
|
Globela Pharma Private Limited.
|
India
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DRP-15139
|
Lidocaine Hydrochloride
|
Lidonem
|
20 mg/mL (2% w/v)
|
Solution for Injection (I.V.)
|
Local Anesthetic
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DRP-15210
|
Co-Amoxiclav
|
Moxinova CV
|
228.5 mg/5 mL
|
Powder for Oral Suspension
(Orange Flavor)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
28 May 2024
|
28 May 2029
|
| View |
|
DRP-15242
|
Gliclazide
|
Gliclyde
|
60 mg
|
Modified Release Tablet
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
S Kant Healthcare Limited
|
India
|
Initial
|
30 May 2024
|
30 May 2029
|
| View |
|
DRP-15211
|
Tramadol Hydrochloride
|
Tramanov-50
|
50 mg
|
Capsule
|
Opioid Analgesic
|
Acme Formulation Pvt. Ltd.
|
India
|
Initial [Re-application]
|
28 May 2024
|
28 May 2029
|
| View |
|
DRP-15220
|
Vildagliptin
|
None
|
50 mg
|
Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Medochemie (Far East) Ltd., (Oral Facility)
|
Vietnam
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DR-XY49099
|
Losartan Potassium + Hydrochlorothiazide
|
Altrazide
|
50 mg/12.5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB) and Diuretic
|
CB Healthcare
|
India
|
Initial
|
29 May 2024
|
29 May 2029
|
| View |
|
DR-XY48821
|
Gabapentin
|
Unogaba 400
|
400 mg
|
Capsule
|
Gabapentinoid
|
Steril-Gene Life Sciences (P) Limited
|
India
|
Initial (Correction)
|
29 May 2024
|
27 July 2028
|
| View |
|
DR-XY49100
|
Flucloxacillin
|
Khrizfloxin
|
500 mg
|
Capsule
|
Antibacterial (Beta-Lactamase Resistant Penicillin)
|
Sparsh Bio-Tech Pvt. Ltd.
|
India
|
Initial
|
31 May 2024
|
31 May 2029
|
| View |
|
DRP-15253
|
Furosemide
|
Diura
|
10 mg/mL
|
Solution for Injection (IM/IV)
|
Diuretic (Sulfonamide)
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Initial
|
31 May 2024
|
31 May 2026
|
| View |
|
DRP-15254
|
Azithromycin (as dihydrate)
|
Azmyn IV
|
500 mg
|
Powder for Solution for I. V. Infusion
|
Antibacterial for Systemic Use (Macrolide)
|
Alwin DMD Pharmaceuticals
|
India
|
Initial
|
31 May 2024
|
31 May 2029
|