| View |
|
DRP-11814
|
Febuxostat
|
Saphxostat-80
|
80 mg
|
Film-Coated Tablet
|
Antigout
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
02 May 2022
|
02 May 2027
|
| View |
|
DRP-11788
|
Gabapentin
|
Gabasaph-300
|
300 mg
|
Capsule
|
Antiepileptic
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11787
|
Piroxicam
|
Piroxisaph-20
|
20 mg
|
Capsule
|
Non-Steroidal Anti-inflammatory Drug (NSAID)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11792
|
Dexmedetomidine (As Hydrochloride)
|
Dexmed
|
100 mcg/ mL (200 mcg/2 mL)
|
Concentrate Solution for Intravenous Infusion
|
Hypnotic/Sedative
|
Gland Pharma Limited
|
India
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DR-XY47988
|
Hidrosmin
|
Venosmil
|
200mg
|
Capsule
|
Capillary Stabilizing Agent (Bioflavonoid)
|
Faes Farma, S.A.
|
Spain
|
Monitored Release (MR)
|
29 April 2022
|
29 April 2027
|
| View |
|
DR-XY47994
|
Teneligliptin (as hydrobromide hydrate)
|
Tenemax
|
20 mg
|
Film-Coated Tablet
|
Antidiabetic Agent (Dipeptidyl peptidase 4 (DPP-4) inhibitors)
|
Ajanta Pharma Limited
|
India
|
Monitored Release (MR) (Correction)
|
21 May 2024
|
02 May 2027
|
| View |
|
DRP-11694
|
Cephalexin
|
Sanceph-500 Cap
|
500 mg
|
Capsules
|
Antibacterial (Cephalosporin)
|
Sance Laboratories Pvt. Ltd.
|
India
|
Initial (Correction)
|
30 June 2022
|
04 May 2027
|
| View |
|
DR-XY47991
|
Dolutegravir (as sodium)
|
Doluvir
|
50 mg
|
Film Coated Tablet
|
Antiviral (Integrase Inhibitor)
|
Micro Labs Limited
|
India
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
DR-XY47989_PI_01.pdf
|
DR-XY47989
|
Olmesartan Medoxomil + Amlodipine (as besilate)
|
Alzor CCB
|
40mg/10mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blockers (ARBs) and Calcium Channel Blockers
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release status) [Reconstruction]
|
08 February 2023
|
29 April 2027
|
| View |
|
DRP-11542
|
Midazolam (as hydrochloride)
|
None
|
1 mg/mL (5 mg/5 mL)
|
Solution for Injection/Infusion (IM/IV/Rectal)
|
Hypnotic/Sedative (Benzodiazepine derivative)
|
Siegfried Hameln GmbH
|
Germany
|
Initial
|
05 May 2022
|
05 May 2027
|
| View |
|
DRP-11545
|
Midazolam (as hydrochloride)
|
None
|
5 mg/mL
|
Solution for Injection/Infusion (IM/IV/Rectal)
|
Hypnotic/Sedative (Benzodiazepine derivative)
|
Siegfried Hameln GmbH
|
Germany
|
Initial
|
05 May 2022
|
05 May 2027
|
| View |
|
DR-XY47970
|
Drospirenone + Ethinylestradiol
|
Yanci-30
|
3mg / 30mcg
|
Tablet
|
Hormonal Contraceptive
|
Mylan Laboratories Ltd.
|
India
|
Initial
|
04 May 2022
|
04 May 2027
|
| View |
|
DR-XY47995
|
Drospirenone + Ethinylestradiol
|
Yanci 20
|
3mg/20mcg
|
Tablet
|
-
|
Mylan Laboratories Ltd.
|
India
|
-
|
04 May 2022
|
04 May 2027
|
| View |
DR-XY47999_PI_01.pdf
|
DR-XY47999
|
Efavirenz + Lamivudine + Tenofovir disoproxil
fumarate
|
Tenolam - E
|
600 mg/300 mg/300 mg
|
Film Coated Tablet
|
Antiviral Combination
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release
|
05 May 2022
|
05 May 2025
|
| View |
DR-XY47998_PI_01.pdf
|
DR-XY47998
|
Lamivudine + Tenofovir disoproxil fumarate
|
Tenolam
|
300 mg / 300 mg
|
Film-Coated Tablet
|
Antiviral Combination
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release
|
05 May 2022
|
05 May 2025
|
| View |
|
DR-XY48001
|
Solifenacin succinate
|
Solitor 5
|
5 mg
|
Film-Coated Tablet
|
Urological
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial (Correction)
|
19 January 2023
|
05 May 2027
|
| View |
DR-XY48002_PI_01.pdf
|
DR-XY48002
|
Dolutegravir (as sodium) + Lamivudine + Tenofovir
disoproxil fumarate
|
None
|
50 mg/ 300 mg/ 300 mg
|
Film-Coated Tablet
|
Antiviral Combination
|
Hetero Labs Limited
|
India
|
Monitored Release
|
05 May 2022
|
05 May 2025
|
| View |
|
DR-XY48000
|
Fenofibrate
|
None
|
200 mg
|
Capsule
|
Lipid Modifying Agent (Fibrates)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
05 May 2022
|
05 May 2027
|
| View |
|
DR-XY47981
|
Salbutamol (as sulfate) + Guaifenesin
|
Izbrid
|
1mg/ 50mg
|
Syrup (Orange Flavor)
|
Bronchodilator/ Expectorant
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11831
|
Gefitinib
|
Figet
|
250mg
|
Film-Coated Tablet
|
Antineoplastic [Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor]
|
Remedica Ltd.
|
Cyprus
|
Initial
|
05 May 2022
|
05 May 2027
|