| View |
|
DRP-14760
|
Sodium Hyaluronate
|
Eyesod
|
1mg/mL (0.1 w/v)
|
Ophthalmic Solution (Eye Drops)
|
Dysfunctional Tear Syndrome (Lubricant)
|
Makcur Laboratories Limited
|
India
|
Initial [OTC]
|
21 December 2023
|
21 December 2028
|
| View |
|
DRP-14758
|
Sodium Hyaluronate
|
Hylasod
|
1mg/mL (0.1 w/v)
|
Ophthalmic Solution (Eye Drops)
|
Dysfunctional Tear Syndrome (Lubricant)
|
Makcur Laboratories Limited
|
India
|
Initial [OTC]
|
21 December 2023
|
21 December 2028
|
| View |
|
DRP-14697
|
Dextromethorphan hydrobromide + Guaifenesin +
Phenylephrine hydrochloride
|
Exicof (Raspberry Flavor)
|
30mg/200mg/10mg per 10mL
|
Syrup
|
Cough Suppressant/Expectorant/Decongestant
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
21 December 2023
|
21 December 2028
|
| View |
|
DRP-14759
|
Mupirocin
|
Mupros
|
20 mg/g (2% w/w)
|
Ointment
|
Antibacterial
|
East African (India) Overseas
|
India
|
Initial
|
21 December 2023
|
21 December 2028
|
| View |
|
DRP-14678
|
Multivitamins+ Iron
|
Mirovit
|
(see reverse for formulation)
|
Capsule
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (Correction)
|
21 December 2023
|
28 November 2028
|
| View |
|
DRP-14712
|
Clotrimazole
|
Clobon DS
|
20 mg per gram (2% w/w)
|
Topical Cream
|
Antifungal
|
NEXT WAVE (INDIA)
|
India
|
Initial
|
13 December 2023
|
13 December 2028
|
| View |
|
BR-1461
|
Ocrelizumab
|
Ocrevus
|
300 mg/10 ml (30 mg/ml)
|
oncentrate for Solution for
Intravenous Infusion
|
Selective Immunosuppresant
|
F. Hoffmann-La Roche Ltd.
|
Switzerland
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
BR-1462
|
Ocrelizumab
|
Ocrevus
|
300 mg/10 ml (30 mg/ml)
|
Concentrate for Solution for
Intravenous Infusion.
|
Selective Immunosuppresant
|
Roche Diagnostics GmbH
|
Germany
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
BR-1460
|
Infliximab
|
Remsima
|
120 mg
|
Solution For Injection
|
Immunosuppressant
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
DRP-14761
|
Ampicillin (As Sodium) + Sulbactam (As Sodium)
|
Incillin Plus 1500
|
1 g/ 500 mg
|
Powder For Injection (I.M./I.V.)
|
Antibacterial (Penicillin-Beta-lactamase Inhibitor
Combination)
|
Injectcare Parenterals Pvt Ltd
|
India
|
Initial
|
22 December 2023
|
22 December 2028
|
| View |
|
DR-XY48956
|
Amlodipine (as besilate)
|
Khrizdipine 10
|
10 mg
|
Tablet
|
Anti-Hypertensive And Anti-Anginal Agent
|
Celogen Generics Private Ltd.
|
India
|
Initial
|
22 December 2023
|
22 December 2028
|
| View |
|
DR-XY48962
|
Paracetamol
|
None
|
10 mg/mL
|
Solution for Injection (IV)
|
-
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
22 December 2023
|
22 December 2028
|
| View |
|
DR-XY48958
|
Eslicarbazepine (as acetate)
|
Excarb 200
|
200 mg
|
Tablet
|
Antiepileptic
|
TORRENT PHARMACEUTICALS LTD.
|
India
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
DR-XY48959
|
Eslicarbazepine (as acetate)
|
Excarb 400
|
400 mg
|
Tablet
|
Antiepileptic (Carboxamide Derivative)
|
TORRENT PHARMACEUTICALS LTD.
|
India
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
DR-XY48960
|
Eslicarbazepine (as acetate)
|
Excarb 600
|
600 mg
|
Tablet
|
Antiepileptic (Carboxamide Derivative)
|
TORRENT PHARMACEUTICALS LTD.
|
India
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
DR-XY48961
|
Eslicarbazepine (as acetate)
|
Excarb 800
|
800 mg
|
Tablet
|
Antiepileptic (Carboxamide Derivative)
|
TORRENT PHARMACEUTICALS LTD.
|
India
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
DR-XY48957_PI_01.pdf
|
DR-XY48957
|
Doxylamine Succinate + Pyridoxine Hydrochloride
|
Diclegis
|
10mg/10mg
|
Delayed-Release Tablet
|
Antihistamine (Aminoalkyl ether)
|
Duchesnay Inc.
|
Canada
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
DRP-14679
|
Multivitamins + Iron
|
Ronibon
|
Each capsule contains:
Iron (equivalent to 325 my Ferrous fumarate) 107 mg
Ascorbic Acid (Vitamin C) 100 mg
Niacin (Vitamin B1) 25 mg
Thiamine mononitrate (Vitamin B1) 10 mg
Riboflavin (Vitamin B1) 10 mg
Calcium pantothenate (Vitamin Bs) 10 mg
Pyridoxine hydrochloride (Vitamin B6) 5 mg
Folic Acid (Vitamin B9) 950 mcg
Cyanocobalamin (Vitamin B12) 25 mg
|
Capsule
|
Vitamins / Mineral
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
21 December 2023
|
28 November 2028
|
| View |
|
DRP-10175
|
Nifedipine
|
Adapine S.R.F.C.
|
30 mg
|
Sustained-Release Tablet
|
-
|
Standard Chem. & Pharm Co., Ltd.
|
Taiwan
|
Initial (Variation: PCPR Conversion)
|
04 August 2021
|
26 April 2026
|
| View |
|
DRP-13931
|
Enalapril maleate
|
Enaprimed-10
|
10mg
|
Tablet
|
-
|
Saga Lifesciences Limited
|
India
|
Initial
|
18 May 2023
|
18 May 2028
|