| View |
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DRP-11625
|
Mupirocin
|
Muporig
|
20mg / g (2% w/w)
|
Ointment
|
Antibacterial (Antibiotic for Topical Use)
|
Next Wave (India)
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11603
|
Hydrocortisone
|
Cortillen
|
500 mg
|
Powder For Injection (I.M/I.V)
|
Corticosteroid
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
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DRP-11602
|
Dexamethasone (as sodium phosphate)
|
Dexollen
|
4 mg/mL (8 mg/2 mL)
|
Solution for Injection (IM/IV)
|
Corticosteroid
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11642
|
Phenylephrine Hydrochloride + Brompheniramine
Maleate
|
Saphtinamine-Plus
|
12.5 mg/4 mg per 5 mL
|
Syrup (Grape Flavor)
|
Nasal Decongestant/Antihistamine
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
05 April 2022
|
05 April 2027
|
| View |
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DRP-11626
|
Phenylephrine Hydrochloride + Brompheniramine
Maleate
|
Phenbrosaph-Plus
|
12.5 mg/4 mg per 5 mL
|
Syrup (Grape Flavor)
|
Nasal Decongestant/Antihistamine
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11627
|
Phenylephrine Hydrochloride + Brompheniramine Maleate
|
Saphtinamine-1
|
1 mg/0.8 mg per mL
|
Syrup (Oral Drops) (Orange Flavor)
|
Nasal Decongestant/Antihistamine
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11629
|
Phenylephrine Hydrochloride + Chlorphenamine
Maleate
|
Saphlerine-1
|
1 mg/0.8 mg per mL
|
Syrup (Oral Drops) (Orange Flavor)
|
Nasal Decongestant/Antihistamine
|
zine Healthcare Pvt. Ltd.
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11628
|
Phenylephrine Hydrochloride + Chlorphenamine Maleate
|
Saphendrine-1
|
1 mg/0.8 mg per mL
|
Syrup (Oral Drops)
|
Nasal Decongestant/Antihistamine
|
zine Healthcare Pvt. Ltd.
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11666
|
Paracetamol
|
Remol 125
|
125 mg/5 mL
|
Oral Suspension
|
ANalgesic / Antipyretic
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial (OTC)
|
07 April 2022
|
07 April 2027
|
| View |
|
HRP-510
|
Hydroquinone + Tretinoin
|
Peel-Away (Exfoliant Solution 1)
|
2 g (2% w/w/10 mg (0.01% w/w) per 100 mL
|
Topical
Solution (Cucumber Scent)
|
Anti-Ance/ Depigmenting Agent
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (HR)
|
05 April 2022
|
05 April 2027
|
| View |
|
HRP-511
|
Hydroquinone + Tretinoin
|
Peel-Away (Exfoliant Solution 2)
|
2 g (2% w/w)/25 mg (0.025% w/w) per 100 mL
|
Topical
Solution (Cucumber Scent)
|
Anti-Ance/ Depigmenting Agent
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (HR)
|
05 April 2022
|
05 April 2027
|
| View |
|
HRP-512
|
Hydroquinone + Tretinoin
|
Peel-Away (Exfoliant Solution 3)
|
2 g (2% w/w)/25 mg (0.025% w/w) per 100 mL
|
Topical
Solution (Cucumber Scent)
|
Anti-Ance/ Depigmenting Agent
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (HR)
|
05 April 2022
|
05 April 2027
|
| View |
|
DRP-11579
|
Ascorbic Acid
|
Ascortec
|
500 mg
|
Chewable Tablet
|
Vitamin
|
SM Pharmaceutical (M) SDN. BHD.
|
Malaysia
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY47854
|
Iron + Folic acid
|
Raricap Forte
|
50 mg (equivalent to 605 mg Ferrous calcium citrate) /
300 mcg
|
Film-Coated Tablet
|
Hematinic
|
Bafna Pharmaceuticals, Ltd
|
India
|
Initial
|
30 March 2022
|
30 March 2025
|
| View |
|
DR-XY47875
|
Pregabalin
|
Neurokem
|
150 mg
|
Capsule
|
-
|
Alkem Laboratories Ltd.
|
India
|
-
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47874
|
Omeprazole (as sodium)
|
None
|
40 mg
|
Lyophilized Powder for I.V. Injection
|
Proton Pump Inhibitor
|
Steril-Gene Life Sciences Pvt. Ltd.
|
India
|
Initial (Re-application)
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47881
|
Metoprolol tartrate
|
M-Card
|
1 mg/mL
|
Solution for I.V. Injection
|
Beta Blocker
|
Baxter Pharmaceuticals India Private Limited
|
India
|
Monitored Release
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11592
|
Ceftriaxone (as sodium) + Sulbactam (as sodium)
|
Ambicef-S
|
1.5 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin-Beta-Lactamase Inhibitor Combination)
|
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co.,
Ltd.
|
China
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
DR-XY47892_PI_01.pdf
|
DR-XY47892
|
Metformin hydrochloride + Gliclazide + Pioglitazone
(as hydrochloride)
|
Trizeric
|
500 mg/80 mg/15 mg
|
Film-Coated Tablet
|
Oral Blood Glucose Lowering Drug Combination
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
04 April 2022
|
04 April 2027
|
| View |
HMR-171_PIL_01.pdf
|
HMR-171
|
Carica papaya (Papain) + Anethum graveolens L. (Dill
oil fruit) + Pimpinella anisum L. (Anise oil fruit) +
Carum carvi L. (Caraway oil fruit) + Alpha amylase
|
Neopeptine
|
10 mg/2 mg/2 mg/2 mg/20 mg per mL
|
Syrup (Oral
Drops)
|
Herbal Medicine (for the treatment of indigestion and flatulence)
|
Raptakos Brett & Co. Ltd.
|
India
|
Initial
|
30 March 2022
|
30 March 2027
|