| View |
|
DRP-12510
|
Celecoxib
|
None
|
400 mg
|
Capsule
|
-
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial
|
25 August 2022
|
25 August 2027
|
| View |
|
DRP-12483
|
Tioconazole+Tinidazole
|
Novotran
|
100mg/150mg
|
Vaginal Suppository
|
Antibacterial/ Antiprotozoal/ Antifungal
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
18 August 2022
|
18 August 2027
|
| View |
|
DRP-12474
|
Bisoprolol Fumarate
|
Bisotrol 5
|
5 mg
|
Tablet
|
-
|
Ipca Laboratories Ltd.
|
India
|
Initial
|
16 August 2022
|
16 August 2027
|
| View |
|
DRP-12475
|
Bisoprolol Fumarate
|
Bisotrol 10
|
10 mg
|
Film-Coated Tablet
|
Beta Blocking Agent
|
Ipca Laboratories Ltd.
|
India
|
Initial
|
16 August 2022
|
16 August 2027
|
| View |
|
DR-XY48298
|
Rasagiline (as mesilate)
|
Rasator 0.5
|
500 mcg
|
Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
18 August 2022
|
18 August 2025
|
| View |
|
DRP-12472
|
Pregabalin
|
Neuro D 150
|
150mg
|
Capsule
|
Antiepileptic
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
16 August 2022
|
16 August 2027
|
| View |
|
DRP-12484
|
Pregabalin
|
Neuro D 75
|
75 mg
|
Capsule
|
Antiepileptic
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
18 August 2022
|
18 August 2027
|
| View |
BR-1411_PI_01.pdf
|
BR-1411
|
Semaglutide
|
Rybelsus
|
7 mg
|
Tablet
|
Glucagon-like Peptide-1 (GLP-1) Analogue
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release
|
18 August 2022
|
18 August 2027
|
| View |
BR-1412_PI_01.pdf
|
BR-1412
|
Semaglutide
|
Rybelsus
|
14 mg
|
Tablet
|
Glucagon-like Peptide-1 (GLP-1) Analogue
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release
|
18 August 2022
|
18 August 2027
|
| View |
|
DRP 1809
|
Metoprolol Tartrate
|
Prolol
|
100 mg
|
Tablet
|
-
|
Centurion Laboratories Pvt. Ltd.
|
India
|
initial (Variation)
|
25 August 2022
|
25 August 2027
|
| View |
DRP-10015_PI_01.pdf
|
DRP-10015
|
Cloxacillin (As Sodium)
|
Solaze
|
125 mg/5 mL
|
Powder For Solution
|
Antibacterial (Penicillin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
22 July 2023
|
25 November 2028
|
| View |
DRP-10017_PI_01.pdf
|
DRP-10017
|
Cloxacillin (as sodium)
|
Solaze
|
250 mg per 5 mL
|
Powder For Solution
|
Antibacterial (Penicillin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Renewal
|
29 September 2024
|
07 January 2030
|
| View |
DRP-10019_PI_01.pdf
|
DRP-10019
|
Cloxacillin (As Sodium)
|
Solaze
|
500 mg
|
Capsule
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal (Variation: PCPR Conversion) correction
|
19 August 2022
|
18 December 2025
|
| View |
|
DR-XY48104
|
Remifentanil (as hydrochloride)
|
Remifen
|
1 mg
|
Lyophilized Powder for Solution for Injection or Infusion (IV)
|
-
|
Laboratorios Normon, S.A.
|
Spain
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12482
|
Brimonidine Tartrate
|
None
|
2 mg/mL (0.2%w/v)
|
Ophthalmic Solution
|
Antiglaucoma
|
Indoco Remedies Limited
|
india
|
Initial
|
17 August 2022
|
17 August 2025
|
| View |
|
DRP-12518
|
Salbutamol
|
Levomol
|
252 mcg/mL (630 mcg/2.5 mL)
|
Solution for Inhalation
|
Selective beta-2-adrenoreceptor agonists
|
AXA Parenterals Ltd.
|
India
|
Monitored Release
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12476
|
Cabazitaxel
|
Cabitas
|
20 mg/mL
|
Concentrate for Solution for IV Infusion
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
17 August 2022
|
17 August 2027
|
| View |
|
DR-XY48311
|
Bupropion Hydrochloride
|
Bupron XL 300
|
300 mg
|
Extended Release Tablet
|
Anti-depressant
|
Sun Pharmaceutical Industries Limited.
|
India
|
Monitored Release (Variation) (Reconstruction)
|
31 July 2024
|
25 August 2027
|
| View |
|
DR-XY48312
|
Bupropion Hydrochloride
|
Bupron XL 150
|
150 mg
|
Extended Release Tablet
|
Anti-depressant
|
Sun Pharmaceuticals Industries Limited
|
India
|
Monitored Release (Variation) (Reconstruction)
|
31 July 2024
|
25 August 2027
|
| View |
|
BR-1414
|
Hepatitis B Vaccine (rDNA)
|
Bevac
|
10mcg/0.5mL (100mcg/5mL)
|
Solution for Injection (I.M)
|
Vaccines
|
Biological E. Limited
|
India
|
Initial
|
23 August 2022
|
23 August 2027
|