| View |
|
DRP-12353
|
Fexofenadine Hydrochloride
|
Fexdion
|
180mg
|
Film Coated Tablets
|
Antihistamine
|
Globela Pharma Private Limited
|
India
|
Initial
|
22 July 2022
|
22 July 2027
|
| View |
|
DRP-12352
|
Fexofenadine Hydrochloride
|
Fexdion
|
120mg
|
Film Coated Tablets
|
Antihistamine
|
Globela Pharma Private Limited
|
India
|
Initial
|
22 July 2022
|
22 July 2027
|
| View |
|
DR-XY48226
|
Ranolazine
|
Razine
|
500mg
|
Extended-Release Tablet
|
Anti-Angina
|
Ajanta Pharma Limited
|
India
|
Initial [correctio]
|
22 August 2022
|
26 July 2027
|
| View |
|
DR-XY48200
|
Febuxostat
|
Febutor - 80
|
80 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
19 July 2022
|
19 July 2027
|
| View |
|
DR-XY48201
|
Febuxostat
|
Febutor-40
|
40 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
DR-XY48224_PI_01.pdf
|
DR-XY48224
|
Neostigmine Methylsulfate
|
Neostin 10
|
1 mg/mL (10 mg/10 mL)
|
Solution for Injection (I.M./I.V./S.C.)
|
-
|
Aspiro Pharma Limited
|
India
|
Monitored Release (Correction)
|
31 August 2022
|
26 July 2027
|
| View |
|
DRP-12312
|
Esomeprazole (as magnesium trihydrate)
|
Esomeprasaph-40
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
15 July 2022
|
15 July 2027
|
| View |
|
DR-XY48209
|
Diclofenac Sodium
|
Diclosafe
|
100 mg
|
Rectal Suppository
|
Non-steroid Antiinflammatory and Antirheumatic
Product
|
Kusum Healthcare Pvt. Ltd. (Block II)
|
India
|
Monitored Release
|
21 July 2022
|
21 July 2027
|
| View |
|
DR-XY48195
|
Mesalazine
|
Pentasa
|
2 g
|
Prolonged Release Granules
|
Prolonged - Release Granules : Intestinal Anti-inflammatory Agent (Aminosalicylic
acid/Similar Agent)
|
Ferring International Center SA
|
Switzerland
|
Monitored Release
|
15 July 2022
|
15 July 2027
|
| View |
|
DRP-12310
|
Busulfan
|
Bufacord
|
60 mg/10 mL
|
Concentrate Solution for Intravenous Infusion
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Monitored Release
|
21 July 2022
|
21 July 2027
|
| View |
DR-XY48220_PI_01.pdf
|
DR-XY48220
|
Budesonide + Formoterol Fumarate Dihydrate
|
Fortra
|
200 mcg/ 6 mcg per Actuation
|
Metered Dose Pressurized Inhalation Suspension
|
Adrenergic-Corticosteroid Combination
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Monitored Release (Correction)
|
01 September 2022
|
25 July 2027
|
| View |
|
DR-XY48229
|
Isosorbide Mononitrate
|
Vasotrate-120 OD
|
120 mg
|
Extended-Release Tablet
|
Vasodilator (Anti-angina)
|
Torrent Pharmaceuticals, Ltd.
|
India
|
Monitored Release (MR)
|
26 July 2022
|
26 July 2027
|
| View |
|
DRP-12297
|
Amoxicillin (as trihydrate)
|
Seamox 500
|
500 mg
|
Capsule
|
-
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
|
DR-XY48233
|
Sodium Hyaluronate
|
Osflex
|
25 mg/2.5 mL (10 mg/mL)
|
Solution for Injection in
Prefilled Syringe
|
Anti-Rheumatoid
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Monitored Release
|
27 July 2022
|
27 July 2027
|
| View |
|
DRP-11785
|
Levocetirizine Dihydrochloride
|
Levothix
|
5 mg
|
Orally Disintegrating Tablet
|
Antihistamine
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Monitored Release
|
15 July 2022
|
15 July 2027
|
| View |
|
DRP-12195
|
Folinic acid (as calcium folinate)
|
Fonkonat
|
10 mg/mL
|
Solution for Injection (IM/IV)
|
Detoxifying agent for antineoplastic treatment
|
PT. Fonko International Pharmaceuticals
|
Indonesia
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
|
DR-XY48218
|
Diquafosol sodium
|
Diquas-S
|
30 mg/mL (3% w/v)
|
Ophthalmic Solution
|
P2Y2 (Purinoceptor) Agonist
|
Huons Co., Ltd.
|
Korea
|
Monitored Release
|
21 July 2022
|
21 June 2027
|
| View |
|
DR-XY48160
|
Cefepime (as hydrochloride)
|
Cephalex
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Fourth-generation cephalosporin)
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
|
DR-XY48183
|
Mycophenolic Acid
|
Mycofena DR
|
360 mg
|
Delayed Release Tablet
|
Immunosuppressant
|
Alkem Laboratories Limited
|
India
|
Initial
|
21 July 2022
|
21 July 2027
|
| View |
|
DRP-12345
|
Ascorbic Acid
|
Vitakon-C
|
100 mg/mL (500 mg/5 mL)
|
Solution for Injection
(IM/IV)
|
Vitamin
|
Scott-Edil Pharmacia Limited
|
India
|
Initial
|
21 July 2022
|
21 July 2027
|