| View |
|
DRP-12835
|
Hydroxychloroquine Sulfate
|
Accoquin
|
200mg
|
Film-Coated Tablet
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
14 October 2022
|
14 October 2027
|
| View |
|
DRP-12793
|
Pregabalin
|
Pregab
|
75 mg
|
Capsule
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12799
|
Vancomycin (as hydrochloride)
|
Vancosaph-500
|
500mg
|
Lyophilized Powder for IV Infusion
|
Antibacterial (Glycopeptide)
|
Kilitch Drugs India Ltd.
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12798
|
Vancomycin (as hydrochloride)
|
Vancosaph-1000
|
1 g
|
Lyophilized Powder for IV Infusion
|
Antibacterial (Glycopeptide)
|
Kilitch Drugs India Ltd.
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12800
|
Cefuroxime (As Sodium)
|
Zefuvee
|
750mg
|
Powder for Injection (IV/IM)
|
Antibacterial (Second Generation Cephalosporin)
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
BR-981
|
Epoetin Alfa
|
Renogen
|
10,000 IU/mL
|
Solution for Injection (IV/SC)
|
Antianemic Preparations
|
Intas Pharmaceuticals, Ltd.
|
India
|
Renewal
|
24 May 2024
|
03 October 2029
|
| View |
|
DRP - 11525
|
Levofloxacin
|
Levonova-500
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
Ratnamani Healthcare Pvt. Ltd.
|
India
|
Initial (Correction)
|
13 October 2022
|
31 March 2027
|
| View |
|
DRP-12041-01
|
Anastrozole
|
AnnaGet
|
1 mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
CLIDP Conversion
|
02 November 2022
|
01 June 2027
|
| View |
|
DRP-12213-04
|
Cefuroxime (as axetil)
|
Temlex
|
500 mg
|
Film-Coated Tablet
|
-
|
NGB Laboratories Pvt. Ltd.
|
India
|
CLIDP Conversion
|
02 November 2022
|
13 July 2027
|
| View |
|
DRP-8812-02
|
Paclitaxel
|
Belcytax
|
6 mg/mL
|
Solution for Injection (IV Infusion)
|
-
|
Biolyse Pharma Corporation
|
Canada
|
CLIDP Conversion
|
29 October 2022
|
15 December 2026
|
| View |
|
DRP-9478-01
|
Rosuvastatin (as calcium)
|
Zyrova
|
40 mg
|
Film-Coated Tablet
|
-
|
Umedica Laboratories Pvt. Ltd
|
India
|
CLIDP Conversion
|
29 October 2022
|
25 October 2026
|
| View |
|
DRP-11401-02
|
Capecitabine
|
Capegen
|
500 mg
|
Film-Coated Tablet
|
-
|
Laboratorio Eczane Pharma S.A.
|
Argentine Republic
|
Automatic Renewal
|
29 October 2022
|
09 March 2027
|
| View |
|
DR-XY38958 (FOR EXPORT ONLY)
|
Cefdinir
|
Omnicef
|
125mg/5mL
|
Powder for Oral Suspension
|
-
|
Interphil Laboratories, Inc
|
Philippines
|
Renewal
|
29 October 2022
|
18 January 2026
|
| View |
|
DRP-4474-11
|
Ceftriaxone (As Sodium)
|
Tirifex
|
1 g
|
Powder For Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
Brawn Laboratories Ltd.
|
India
|
Automatic Renewal
|
26 October 2022
|
13 June 2028
|
| View |
|
DRP-4364-04
|
Clobetasol (As Propionate)
|
Clobimed
|
0.05% (0.5 mg/g)
|
Ointment
|
Corticosteroid
|
Rainbow Lifesciences Pvt. Ltd.
|
India
|
Automatic Renewal
|
25 October 2022
|
08 April 2028
|
| View |
|
DRP-4384-04
|
Citicoline (as sodium)
|
None
|
500 mg
|
Film-Coated Tablet
|
Psychoanaleptic (Other psychostimulant and nootropic)
|
Akums Drugs & Pharmaceuticals Ltd
|
India
|
CLIDP Conversion
|
25 October 2022
|
25 April 2028
|
| View |
|
DRP-7380-02
|
Ascorbic Acid + Zinc
|
Rapid-C Plus
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/10 mg (equivalent to 27.5 mg Zinc Sulfate monohydrate) per Capsule
|
|
Vitamin/Mineral
|
AZARIAS PHARMACEUTICAL LABORATORIES INC.
|
Philippines
|
Renewal
|
24 October 2022
|
02 October 2027
|
| View |
|
DR-XY31283
|
Hyoscyamine Sulfate + Atropine Sulfate + Hyoscine Hydrobromide
|
Donnatab (for Export Only)
|
103.7mcg/ 19.4mcg/ 6.5mcg
|
Tablet
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
19 October 2022
|
24 November 2025
|
| View |
|
DRP-615-18
|
Co-Amoxiclav
|
Genclav
|
500mg / 125mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
CLIDP Conversion
|
27 October 2022
|
02 April 2027
|
| View |
|
DRP-10061-03
|
Ketorolac trometamol
|
Ketonob
|
30 mg/mL
|
Solution for Injection (IM/IV)
|
Non-Opioid Analgesic
|
Aju Pharm Co., Ltd.
|
Korea
|
CLIDP Conversion
|
26 October 2023
|
18 September 2028
|