| View |
|
DRP-12730
|
Citicoline (as sodium)
|
Nervigo
|
250 mg/mL (1 g/4 mL)
|
Solution for Injection (I.M./I.V.)
|
-
|
Makcur Laboratories Limited
|
India
|
Initial
|
29 September 2022
|
29 September 2027
|
| View |
|
DRP-12760
|
Carvedilol
|
Carvesaph
|
25 mg
|
Film-Coated Tablet
|
Alpha and Beta Blocking Agent
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
03 October 2022
|
03 October 2027
|
| View |
|
DRP-12759
|
Pregabalin + Methylcobalamin
|
Pregminsaph
|
75 mg/750 mcg
|
Capsule
|
Antiepileptic/Vitamin (Cyanocobalamin
combination
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial Correction]
|
09 February 2023
|
03 October 2027
|
| View |
|
DRP-12741
|
Gefitinib
|
Saphtinib
|
250mg
|
Film-Coated Tablet
|
Antineoplastic Agent
|
Bruck Pharma Private Limited
|
India
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DRP-12749
|
Dextromethorphan Hydrobromide
|
Dextrosaph-15
|
15mg per 5mL
|
Syrup
|
Antitussive
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial [OTC][PCPR]
|
30 September 2022
|
30 September 2027
|
| View |
|
DRHR-2159
|
Chlorhexidine Gluconate
|
Eco-Bath
|
4g/100 mL (4% w/v)
|
Solution (Surgical Scrub)
|
Antiseptic / Disinfectan
|
CareNow Medical Pvt Ltd,
|
India
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DRHR-2162
|
Ethyl Alcohol
|
Alcoplus
|
70% v/v
|
Solution
|
-
|
Oceandeep Industries
|
Philippines
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
|
DRHR-2161
|
Ethyl Alcohol
|
Alcoplus
|
70% v/v
|
Solution
|
Antiseptic/Disinfectant
|
Oceandeep Industries
|
Philippines
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
|
DRHR-2163
|
Ethyl Alcohol
|
Alcoplus
|
70% v/v
|
Solution
|
-
|
Oceandeep Industries
|
Philippines
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
|
DR-XY48397
|
Colecalciferol (Vitamin D3)
|
Soli-D
|
4000 IU
|
Chewable Tablet
|
Vitamin
|
Uždaroji Akcinė Bendrovė "Aconitum"
|
Lithuania
|
Initial (OTC) Correction
|
25 November 2022
|
05 October 2027
|
| View |
|
DRP-12742
|
Sultamicillin (as tosilate dihydrate)
|
Saphtamicill
|
750 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/ Beta-Lactamase Inhibitor)
|
Sunlovis Pharmaceuticals Llp.
|
India
|
Initial (Reconstruction)
|
10 September 2024
|
30 September 2027
|
| View |
|
DRP-12769
|
Ranitidine (as hydrochloride)
|
Zentek
|
25 mg/mL (50 mg/2mL)
|
Solution For Injection (I.M./I.V.)
|
H2 Receptor Antagonist
|
Farbe Firma
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
DRP-12770
|
Tranexamic Acid
|
Actranex
|
500mg
|
Film-Coated Tablet
|
Antifibrinolytic
|
Globela Pharma Private Limited
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
DRP-12756
|
Mefenamic Acid
|
Mefemed
|
250 mg
|
Capsule
|
-
|
Medico Remedies Limited
|
India
|
Initial (OTC)
|
03 October 2022
|
03 October 2025
|
| View |
DR-XY48399_PI_01.pdf
|
DR-XY48399
|
Exemestane
|
Brestane
|
25mg
|
Film-Coated Tablet
|
Aromatase Inhibitor
|
Synthon Hispania S.L.
|
Spain
|
Initial (Reapplication)
|
05 October 2022
|
05 October 2027
|
| View |
|
DRP-12765
|
Paclitaxel
|
Unipacli-100
|
6 mg/mL (100 mg/16.7 mL)
|
Solution for IV Infusion
|
-
|
Admac Lifesciences
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
BR-1423
|
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B
(IDNA) and Haemophilus influenzae Type B Conjugate
Vaccine (Adsorbed)
|
Shan 5
|
Formulation: Each dose (0.5 mL) contains: Diphtheria toxoid-> 30 IU Tetanus toxoid- > 60 IU Bordetella pertussis (Whole Cell)-> 4U Hepatitis B (r-DNA) surface antigen-10 ug Purified capsular polysaccharide of Hib conjugated to 20-40 mcg Tetanus toxoid (carrier protein)-10 ug
|
Suspension For Injection (IM)
|
Vaccines
|
Sanofi Healthcare India Private Limited
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12775
|
Irinotecan Hydrochloride
|
Irnizet 100
|
20 mg/ mL (100 mg/ 5 mL)
|
Concentrate Solution for Injection for I.V. Infusion
|
Antineoplastic (Topoisomerase 1 (TOP1) Inhibitor)
|
Eugia Pharma Specialities Limited
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
DRP-12774
|
Irinotecan Hydrochloride
|
Irnizet 300
|
20 mg/mL (300 mg/15 mL)
|
Concentrate Solution for Injection for I.V. Infusion
|
-
|
Eugia Pharma Specialities Limited
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
DRP-12773
|
Irinotecan Hydrochloride
|
Irnizet 500
|
20 mg/mL (500 mg/25 mL)
|
Concentrate Solution for Injection for I.V. Infusion
|
-
|
Eugia Pharma Specialities Limited
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|