| View |
|
DRP-10421
|
Erythromycin (As Stearate)
|
Erythrophar
|
500 mg
|
Film Coated Tablets
|
Antibacterial (Macrolide)
|
Magbro Healthcare Private Limited
|
India
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11806
|
Metformin hydrochloride
|
Diabemin Xr
|
1 g
|
Extended-Release Tablet
|
Blood Glucose Lowering Drug (Biguanide)
|
PT. Ferron Par Pharmaceuticals
|
Indonesia
|
Initial
|
02 May 2022
|
02 May 2027
|
| View |
|
DR-XY47997
|
Lamivudine + Zidovudine
|
Lavuzid
|
150mg/300mg
|
Film Coated Tablet
|
Antiviral Combination
|
Hetero Labs Limited (Unit III)
|
India
|
Initial
|
05 May 2022
|
05 May 2027
|
| View |
|
DR-XY47990
|
10% Dextrose In Water
|
None
|
100 g/L (10% w/v)
|
Solution for Intravenous Infusion
|
Parenteral Rehydration Solution
|
Shijiazhuang No.4 Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
19 January 2023
|
29 April 2027
|
| View |
|
DRP-11805
|
Co-Amoxiclav
|
Moxinova CV
|
Formulation Each film-coated tablet contains: Amoxicillin (as Trihydrate) .......... 500 mg Clavulanic Acid (as Potassium Clavulanate) ................125 mg
|
Film coated Tablet
|
Antibacterial (Penicillin/Beta-lactamase inhibitor)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
05 May 2022
|
05 May 2027
|
| View |
|
DR-XY48003
|
5% Dextrose In Lactated Ringer'S Solution
|
SITI-D5LR
|
Formulation: Each 100 mL contains: Sodium lactate........3.10 mg Potassium chloride.........30 mg Calcium chloride (dihydrate)...........20 mg Sodium chloride...........600 mg Anhydrous Dextrose........5 g
|
Solution For Intravenous Infusion
|
Electrolyte Replenisher
|
Shijiazhuang No.4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 May 2022
|
05 May 2027
|
| View |
|
DRP-11791
|
Duloxetine Hydrochloride
|
Cymta
|
30 mg
|
Delayed Release Capsule
|
-
|
Standard Chem. & Pharm. Co., Ltd. (Plant II)
|
Taiwan
|
-
|
29 April 2022
|
29 April 2027
|
| View |
|
DR-XY47978
|
Empagliflozin + Metformin Hydrochloride
|
Jardiance Duo
|
5mg/500mg
|
Film-Coated Tablet
|
-
|
Boehringer Ingelheim Ellas A.E.
|
Greece
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DR-XY47975
|
Empagliflozin + Metformin Hydrochloride
|
Jardiance Duo
|
12.5mg/500mg
|
Film-Coated Tablet
|
-
|
Boehringer Ingelheim Ellas A.E
|
Greece
|
-
|
29 April 2022
|
29 April 2027
|
| View |
|
DR-XY47974
|
Empagliflozin + Metformin Hydrochloride
|
Jardiance Duo
|
12.5mg/850mg
|
Film-Coated Tablet
|
-
|
Boehringer Ingelheim Ellas A.E
|
Greece
|
-
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11801
|
Cefuroxime (As Sodium)
|
Zinnagem
|
750mg
|
Powder For Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DR-XY47196
|
Carboplatin
|
Kemocarb
|
10 mg/mL (150 mg/15 mL and 450/45 mL)
|
Solution For IV Infusion
|
Antineoplastic
|
Fresenius Kabi Oncology Limited
|
India
|
Automatic Renewal
|
26 January 2023
|
18 March 2028
|
| View |
|
DRP-8750-01
|
Pregabalin
|
Pregabur
|
75 mg
|
Capsule
|
Anti-epileptic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial (Compliance)
|
04 May 2022
|
21 February 2025
|
| View |
|
DR-XY47968
|
Ascorbic Acid + Zinc
|
Primo C Plus Zinc
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/ 10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin/Mineral
|
Sydenham Laboratories, Inc,
|
Philippines
|
Initial (OTC] (Correction)
|
10 August 2022
|
06 May 2027
|
| View |
|
DRP-11839
|
Ofloxacin
|
Oplase
|
3mg/mL (0.3% w/v)
|
Ophthalmic Solution
|
Antibacterial (Fluoroquinolone)
|
Skymap Healthcare Pvt. Ltd.
|
India
|
Initial
|
06 May 2022
|
06 May 2027
|
| View |
|
DRP-11845
|
Paracetamol + Ibuprofen
|
None
|
325 mg/200 mg
|
Capsule
|
Analgesic/Antipyretic/Non-Steroidal Anti Inflammatory Drug
|
Azarias Pharmaceutical Laboratories Inc,
|
Philippines
|
Initial (OTC)
|
11 May 2022
|
11 May 2027
|
| View |
|
DRP-11849
|
Dutasteride + Tamsulosin Hydrochloride
|
Dutasusaph
|
500 mcg/ 400 mcg
|
Capsule
|
Alpha-adrenoceptor Antagonists
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
10 May 2022
|
10 May 2027
|
| View |
DRP-3871-05_PI_01.pdf
|
DRP-3871-05
|
Irbesartan
|
Irbespeed
|
300mg
|
Tablet
|
Angiotensin II Receptor Blocker
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial (CLIDP)
|
06 May 2022
|
16 May 2026
|
| View |
DRP-3839-06_PI_01.pdf
|
DRP-3839-06
|
Irbesartan
|
Irbespeed
|
150mg
|
Tablet
|
-
|
nterphil Laboratories, Inc.
|
Philippines
|
Initial (CLIDP)
|
06 May 2022
|
16 May 2026
|
| View |
|
DR-XY47993
|
Ascorbic Acid + Zinc + Cholecalciferol (Vitamin D3)
|
Opti-CDZ
|
500 mg (equivalent to 568.18 mg Sodium Ascorbate)/
10 mg (equivalent to 27.5 mg Zinc Sulfate)/1000 IU
|
Capsule
|
Vitamin/Mineral
|
Northfield Laboratories Inc.
|
Philippines
|
Initial
|
06 May 2022
|
06 May 2027
|