| View |
DR-XY48697_PI_01.pdf
|
DR-XY48697
|
Brexpiprazole
|
Rexulti
|
1 mg
|
Film-Coated Tablet
|
-
|
Korea Otsuka Pharmaceutical Co., Ltd.
|
Korea
|
Monitored Release
|
13 April 2023
|
13 April 2028
|
| View |
DR-XY48696_PI_01.pdf
|
DR-XY48696
|
Brexpiprazole
|
Rexulti
|
2 mg
|
Film-Coated Tablet
|
-
|
Korea Otsuka Pharmaceutical Co., Ltd.
|
Korea
|
Monitored Release
|
13 April 2023
|
13 April 2028
|
| View |
DR-XY48694_PI_01.pdf
|
DR-XY48694
|
Brexpiprazole
|
Rexulti
|
4 mg
|
Film-Coated Tablet
|
-
|
Korea Otsuka Pharmaceutical Co., Ltd.
|
Korea
|
Monitored Release
|
13 April 2023
|
13 April 2028
|
| View |
|
DRP-13839
|
Sitagliptin (as phosphate monohydrate)
|
Taglisyd
|
25 mg
|
Film-Coated Tablet
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
27 April 2023
|
27 April 2028
|
| View |
DRP-13840_PI_01.pdf
|
DRP-13840
|
Sitagliptin (as phosphate monohydrate)
|
Taglisyd
|
50 mg
|
Film-Coated Tablet
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
27 April 2023
|
27 April 2028
|
| View |
|
DR-XY48700
|
Prednicarbate
|
Peitel
|
250 mcg/g (0.25% w/w)
|
Topical Cream
|
-
|
Ferrer Internacional, S.A.
|
Spain
|
Monitored Release
|
14 April 2023
|
14 April 2028
|
| View |
|
DRMO-93
|
Medical Grade Oxygen
|
None
|
None
|
None
|
-
|
Handog Industrial Gases Distributors Inc.
|
Philippines
|
Initial
|
25 April 2023
|
25 April 2028
|
| View |
|
DRP-13761
|
Sitagliptin (as phosphate monohydrate)
|
Sitadin
|
50 mg
|
Film-Coated Tablet
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
HRP-590
|
Oral Rehydration Salts
|
Saphlite
|
FORMULATION
Each sachet (4.34 g) contains:
Glucose Anhydrous
2.70 g
Disodium Citrate Dihydrate
0.58 g
Sodium Chloride
0.52 g
Potassium Chloride
0.30 g
|
Powder For Oral Solution (Orange Flavor)
|
-
|
Azine Healthcare Pvt Ltd.
|
India
|
Initial
|
12 April 2023
|
12 April 2028
|
| View |
|
DRP-13746
|
Multivitamins + Minerals
|
Maxxivit
|
Each Film-Coated Tablet contains:
dl - Tocopheryl Acetate (Vitamin E) 30 IU
Ascorbic Acid (Vitamin C) 500 mg
Nicotinamide (Vitamin B3) 100 mg
Iron (as Ferrous Fumarate) 27 mg
Pantothenic Acid (as Calcium Pantothenate)
(Vitamin Bs) 20 mg
Thiamine Hydrochloride (Vitamin B1) 15 mg
Riboflavin (Vitamin B2) 10 mg
Pyridoxine (as Hydrochloride) (Vitamin B6) 5 mg Folic Acid 400 mcg
Biotin 45mcg
Cyanocobalamin (Vitamin B12) 12 mcg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
DRP-13770
|
Ethambutol Hydrochloride
|
Saphetham-200
|
200 mg per 5 mL
|
Syrup
|
-
|
Bueno Salud Care India Pvt. Ltd.
|
India
|
Initial
|
14 April 2023
|
14 April 2028
|
| View |
|
DRP-13769
|
Ethambutol Hydrochloride
|
Saphetham-400
|
400 mg per 5 mL
|
Syrup
|
-
|
Bueno Salud Care India Pvt. Ltd.
|
India
|
Initial
|
14 April 2023
|
14 April 2028
|
| View |
|
DRP-13764
|
Ethambutol hydrochloride
|
Ethambusaph-400
|
400 mg per 5 mL
|
Syrup
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
DRP-13765
|
Ethambutol Hydrochloride
|
Ethambusaph-200
|
200 mg per 5 mL
|
Syrup
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
DRP-13829
|
Colecalciferol (Vitamin D3) + Minerals
|
Calcisaphferol
|
Each tablet contains:
Colecalciferol (Vitamin D1) 400 IU
Calcium
(equivalent to 1500 mg Calcium Carbonate) 600 mg
Magnesium 40 mg
Zinc 7.5 mg
Manganese 2 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
27 April 2023
|
27 April 2028
|
| View |
|
DR-XY48698
|
Apixaban
|
Apxia
|
2.5 mg
|
Film Coated Tablet
|
-
|
Micro Labs Limited
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
DR-XY48699
|
Apixaban
|
Apxia
|
5 mg
|
Film Coated Tablet
|
-
|
Micro Labs Limited
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
DR-XY48695_PI_01.pdf
|
DR-XY48695
|
Brexpiprazole
|
Rexulti
|
3 mg
|
Film Coated Tablet
|
-
|
Korea Otsuka Pharmaceutical Co., Ltd
|
Korea
|
Monitored Release
|
13 April 2023
|
13 April 2028
|
| View |
|
DRP-13762
|
Vildagliptin
|
None
|
50 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
DRP-13757
|
Dextromethorphan Hydrobromide
|
Saphtorphan-10
|
10 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
19 April 2023
|
19 April 2028
|