| View |
|
HRP-507
|
Hydroquinone + Tretinoin
|
Dr. Alvin® Rejuvenating Prime
|
20 mg/0.25 mg per mL (2%/0.025% w/v)
|
Topical Solution
|
Depigmenting Agent/Anti-Acne
|
Carmel Laboratories Inc.
|
Philippines
|
Initial
|
14 March 2022
|
14 March 2027
|
| View |
|
HRP-508
|
Hydroquinone + Tretinoin
|
Dr. Alvin® Rejuvenating Prime
|
20 mg/250 mcg per g (2%/0.025% w/w)
|
Cream
|
Depigmenting Agent/Anti-Acne
|
Carmel Laboratories Inc.
|
Philippines
|
Initial [HR][PCPR)
|
25 May 2022
|
14 March 2027
|
| View |
|
DRP-11445
|
Hydroquinone + Tretinoin
|
Dr. Alvin® Rejuvenating Advance
|
40 mg/250 mcg per mL (4%/0.025% w/v)
|
Topical Cream
|
Depigmenting Agent/Anti-Acne
|
Carmel Laboratories Inc.
|
Philippines
|
Initial
|
14 March 2022
|
14 March 2027
|
| View |
|
DRP-11446
|
Hydroquinone + Tretinoin
|
Dr. Alvin® Rejuvenating Advance
|
40 mg/250 mcg per g (4%/0.025% w/w)
|
Topical Cream
|
Depigmenting Agent/Anti-Acne
|
Carmel Laboratories Inc.
|
Philippines
|
Initial
|
14 March 2022
|
14 March 2027
|
| View |
|
DRP-6717-15
|
Omeprazole (As Sodium)
|
Acimed
|
40 mg
|
Lyophilized Powder for IV Injection
|
Proton Pump Inhibitor
|
Alwin DMD Pharmaceuticals
|
India
|
CLIDP
|
16 March 2022
|
02 June 2026
|
| View |
|
DR-XY26039
|
Ampicillin Sodium
|
Panacta
|
500 mg
|
Powder for Injection (IM/IV)
|
-
|
Panpharma
|
France
|
-
|
11 March 2022
|
20 March 2025
|
| View |
|
DRP-11456
|
Telmisartan + Amlodipine
|
Telmilop
|
40 mg / 10 mg
|
Tablet
|
-
|
Titan Laboratories Pvt. Ltd.
|
India
|
-
|
16 March 2022
|
16 March 2027
|
| View |
|
DRP-11457
|
Sitagliptin
|
Sitagli-100
|
100 mg
|
Film-Coated Tablet
|
-
|
Theon Pharmaceuticals Limited
|
India
|
Initial
|
23 May 2022
|
16 March 2027
|
| View |
|
HRP-505
|
Vitex negundo L. (Lagundi Leaf)
|
Gundisaph-S600
|
600 mg/5 mL
|
Syrup (Orange Flavor)
|
Herbal Medicine (Anti-cough/Anti-asthma)
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
15 March 2022
|
15 March 2027
|
| View |
|
HRP-506
|
Vitex Negundo L. (Nirgundi Leaf)
|
Gundisaph-S600
|
600 mg/5 mL
|
Syrup (Tutti Frutti Flavor)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
-
|
15 March 2022
|
15 March 2027
|
| View |
|
DR-XY44684
|
Olmesartan Medoxomil + Amlodipine (As Besilate)
|
Olmestal-A-25
|
20 mg/5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker/Calcium Channel Blocker
|
Stallion Laboratories Pvt. Ltd.
|
India
|
-
|
16 March 2022
|
29 June 2025
|
| View |
|
DRP-11478
|
Ivabradine (as hydrochloride)
|
Valheart™
|
5 mg
|
Film-Coated Tablet
|
Anti-Angina
|
Krka, D.D., Novo Mesto
|
Slovenia
|
Initial
|
15 March 2022
|
15 March 2027
|
| View |
|
DRP-11477
|
Ivabradine (as hydrochloride)
|
Valheart™
|
7.5 mg
|
Film-Coated Tablet
|
-
|
Krka, D.D., Novo Mesto
|
Slovenia
|
Initial
|
15 March 2022
|
15 March 2027
|
| View |
|
DRP-11475
|
Diclofenac (as Diethylamine) + Methyl Salicylate +
Levomenthol + Linum usitatissimum (Linseed) Seed
|
Dition-Plus
|
0.369g / 3.150 g / 1.575 g / 0.318g (1.16% / 10% / 5% / 1% w/w) per 30g
|
Topical Gel
|
Non-steroidal Anti-inflammatory Drug (NSAID)
|
S Kant Healthcare Limited
|
India
|
Initial (Rx)
|
19 May 2022
|
15 March 2027
|
| View |
|
DRP-11458
|
Tobramycin (as sulfate) + Dexamethasone (as sodium
phosphate)
|
Tobrasaph-Dex
|
3 mg/1 mg (0.3% w/v / 0.1 % w/v) per mL
|
Ophthalmic Suspension (Drops)
|
Antibacterial (Aminoglycoside)/Corticosteroid
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
15 March 2022
|
15 March 2027
|
| View |
|
DRP-11434
|
Ascorbic Acid + Colecalciferol (Vitamin D3) + Zinc
|
None
|
500mg (equivalent to 125mg Ascorbic Acid and
562.50mg Sodium Ascorbate) / 400 IU / 10mg (equivalent to 27.5mg Zinc Sulfate Monohydrate)
|
Chewable Tablet
|
Vitamins / Mineral
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial [OTC]
|
06 June 2022
|
11 March 2027
|
| View |
|
DRP-8325
|
Clotrimazole
|
Candiva
|
10 mg/g (1 %)
|
Cream
|
-
|
Glenmark Pharmaceuticals Ltd.
|
India
|
-
|
17 March 2022
|
06 February 2026
|
| View |
DRP-11496_PI_01.pdf
|
DRP-11496
|
Paclitaxel
|
Macrotaxel
|
6 mg/mL (100mg/16.7mL)
|
Solution For Injection (IV Infusion)
|
-
|
Venus Remedies, Limited
|
India
|
-
|
17 March 2022
|
17 March 2027
|
| View |
|
DRP-11482
|
Orlistat
|
Novastat 120
|
120 mg
|
Capsule
|
Anti-Obesity
|
Acme Generics LLP.
|
India
|
Initial
|
16 March 2022
|
16 March 2027
|
| View |
|
DR-XY47820
|
Colistimethate Sodium
|
Clostin
|
2,000,000 IU
|
Lyophilized Powder For Injection (IV Infusion)
|
-
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Initial
|
23 May 2022
|
16 March 2027
|