| View |
DR-XY47432_PI_01.pdf
|
DR-XY47432
|
Levetiracetam
|
Leveget
|
250mg
|
Film-Coated Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
DR-XY47432
|
06 March 2023
|
06 March 2028
|
| View |
DR-XY47433_PI_01.pdf
|
DR-XY47433
|
Levetiracetam
|
Leveget
|
500mg
|
Film-Coated Tablet
|
Antiepileptic
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
29 September 2021
|
29 September 2026
|
| View |
DR-XY47434_PI_01.pdf
|
DR-XY47434
|
Levetiracetam
|
Leveget
|
1g
|
Film-Coated Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial (Variation)
|
21 February 2023
|
21 February 2028
|
| View |
|
DRP-944-01
|
Sterile Water For Injection
|
None
|
None
|
None
|
-
|
Best Drug Industries, Inc.
|
Philippines
|
-
|
29 September 2021
|
23 February 2025
|
| View |
|
DRP-10467
|
Rosuvastatin (as calcium)
|
Rosusaph-20
|
20 mg
|
Film Coated Tablet
|
HMG CoA Reductase Inhibitor
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (correction)
|
16 March 2023
|
29 September 2026
|
| View |
|
DRP-10466
|
Rosuvastatin (As Calcium)
|
Rosusaph-40
|
40 mg
|
Film Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (correction)
|
16 March 2023
|
29 September 2026
|
| View |
|
DR-XY34686
|
Azithromycin (As Dihydrate)
|
Zithrocin
|
500 mg
|
Tablet
|
Antibacterial (Macrolide)
|
Hizon Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
12 June 2023
|
02 July 2028
|
| View |
|
BR-1371
|
Insulin Human (rDNA)
|
Mixtard 30 Flexpen
|
100 U/mL
|
Suspension for Injection (SC) (30%
Soluble Insulin and 70% Isophane Insulin)
|
-
|
Novo Nordisk Produção Farmacêutica do Brasil Ltda.
|
Brazil
|
Initial
|
24 September 2021
|
24 September 2026
|
| View |
|
HRP-458
|
Paracetamol
|
Naprex
|
100 mg / mL
|
Suspension (Oral Drops) Melon Flavor
|
-
|
Amherst Laboratories Inc.
|
Philippines
|
-
|
24 September 2021
|
19 April 2026
|
| View |
|
HRP-462
|
Paracetamol
|
Naprex
|
120 mg / 5 mL
|
Suspension (Melon Flavor)
|
-
|
Amherst Laboratories Inc.
|
Philippines
|
-
|
24 September 2021
|
07 December 2025
|
| View |
|
HRP-071-05
|
Carbocisteine
|
Plemalis
|
500mg
|
Capsule
|
-
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
-
|
30 September 2021
|
16 July 2026
|
| View |
|
DRP-3495-03
|
Amlodipine (As Besilate)
|
Amlosil
|
10 mg
|
Film-Coated Tablet
|
-
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
Initial
|
29 September 2021
|
26 August 2026
|
| View |
|
BRP-098
|
Enoxaparin Sodium
|
Olxarin
|
4,000 IU/0.4mL (40 mg/0.4 mL)
|
Solution For Injection (SC)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
Initial
|
24 September 2021
|
17 April 2025
|
| View |
|
BRP-096
|
Enoxaparin Sodium
|
Olxarin
|
8,000 IU/0.8mL (80mg/0.8mL)
|
Solution For Injection (SC)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
Initial
|
24 September 2021
|
04 April 2025
|
| View |
|
BRP-097
|
Enoxaparin Sodium
|
Olxarin
|
6,000 IU/0.6mL (60 mg/0.6mL)
|
Solution For Injection (SC)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
Initial
|
24 September 2021
|
04 April 2025
|
| View |
|
BRP-099
|
Enoxaparin Sodium
|
Olxarin
|
2,000 IU/0.2 mL (20mg/0.2 mL)
|
Solution For Injection (SC)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
Initial
|
24 September 2021
|
04 April 2025
|
| View |
|
DR-XY22624
|
Metronidazole
|
Amizol
|
500 mg
|
Tablet
|
Antibacterial/Antiprotozoal (Nitroimidazole derivative)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
24 January 2022
|
05 March 2027
|
| View |
|
DR-XY20552-B
|
Cloxacillin (as Sodium Monohydrate)
|
Axillin
|
250mg
|
Capsule
|
Antibacterial (Penicillin
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal (Revalidation)
|
14 January 2022
|
11 March 2027
|
| View |
|
DR-XY47426
|
Oxacillin (as Sodium)
|
Bactiox
|
500mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Beta-lactamase Resistant Penicillin)
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Renewal
|
28 September 2021
|
28 September 2028
|
| View |
|
DRP-3715
|
Ceftriaxone (as sodium)
|
Trixcef
|
1 g
|
Powder For Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Zazen Pharma Pvt. Ltd.
|
India
|
Renewal
|
27 March 2023
|
28 September 2028
|