| View |
|
DRP-13844
|
Lisinopril (as dihydrate)
|
Liprol
|
10mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
28 April 2023
|
28 April 2028
|
| View |
|
DRP-13804
|
Bisoprolol fumarate
|
Bisophil
|
2.5 mg
|
Film Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
25 April 2023
|
25 April 2028
|
| View |
|
DRP-13803
|
Bisoprolol fumarate
|
Bisophil
|
5 mg
|
Film Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
25 April 2023
|
25 April 2028
|
| View |
|
DRP-13805
|
Bisoprolol fumarate
|
Bisophil
|
10 mg
|
Film Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
25 April 2023
|
25 April 2028
|
| View |
|
DRP-13843
|
Gabapentin
|
Gabarex
|
300 mg
|
Film Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
28 April 2023
|
28 April 2028
|
| View |
|
DRP-13833
|
Apixaban
|
Apixanov-2.5
|
2.5 mg
|
Film-Coated Tablet
|
-
|
Unison Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
26 April 2023
|
26 April 2028
|
| View |
|
DRP-13776
|
Apixaban
|
Apixanov-5
|
5 mg
|
Film Coated Tablet
|
-
|
Unison Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
17 April 2023
|
17 April 2028
|
| View |
|
DRP-13784
|
Amikacin (as sulfate)
|
Amiget
|
250 mg/mL (500 mg/2 mL)
|
Solution for Injection
(I.M./I.V.)
|
-
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Initial
|
19 April 2023
|
19 April 2028
|
| View |
|
DRP-13823
|
Cetirizine Dihydrochloride
|
Allecur D
|
2.5 mg/ mL
|
Syrup (Oral Drops) [Grape Flavor]
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial [OTC]
|
27 April 2023
|
27 April 2028
|
| View |
DRP-13819_PI_01.pdf
|
DRP-13819
|
Oral Rehydration Salts
|
Aplinc-ORS Orange
|
Formulation
Each sachet (4.1g) contains:
Glucose, anhydrous 2.70 g
Trisodium Citrate Dihydrate 580 mg
Sodium Chloride 520 mg
Potassium Chloride 300 mg
|
Granules for Oral
Solution (Orange Flavor)
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial [OTC]
|
27 April 2023
|
27 April 2028
|
| View |
|
DRP-13822
|
Guaifenesin Phenylpropanolamine Hydrochloride +
Chlorphenamine Maleate
|
Plurex
|
100mg/ 6.5mg/ 2mg per 5mL
|
Syrup
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC]
|
27 April 2023
|
27 April 2028
|
| View |
|
DR-XY48701
|
Ascorbic Acid + Zinc
|
Jewel-Zee Plus
|
500 mg/40 mg
|
Capsule
|
-
|
Ashford Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial [OTC]
|
19 April 2023
|
19 April 2028
|
| View |
|
DRP-13792
|
Valacyclovir (as hydrochloride)
|
Valaphil
|
500 mg
|
Film Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
20 April 2023
|
20 April 2028
|
| View |
|
DRP-13791
|
Atropine sulfate
|
Atrophil
|
1 mg/mL
|
Solution for Injection (IM/IV/SC)
|
-
|
Farbe Firma
|
India
|
Initial
|
25 April 2023
|
25 April 2028
|
| View |
|
DRMO-95
|
Medical Grade Oxygen
|
None
|
None
|
None
|
-
|
Oro Oxygen Corporation.
|
Philippines
|
Initial
|
25 April 2023
|
25 April 2028
|
| View |
BR-1441_PI_01.pdf
|
BR-1441
|
Herpes Zoster Vaccine (recombinant, adjuvanted)
|
Shingrix
|
Formulation:
After reconstitution, one dose (0.5 mL) contains:
Varicella Zoster Virus' glycoprotein E antigen23 50 micrograms.
Varicella Zoster Virus = VZV
2adjuvanted with AS01B containing plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms
and
3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 3glycoprotein E (gE) produced in Chinese Hamster Ovarian (CHO) cells by recombinant DNA technology 50 micrograms
|
Powder and Suspension for Suspension for Injection (IM)
|
-
|
GlaxoSmithKline Biologicals S.A.
|
Belgium
|
Monitored Release (MR) (Re-application)
|
02 May 2023
|
02 May 2028
|
| View |
|
DRP-13806
|
Metformin Hydrochloride
|
Metfn
|
850 mg
|
Film-coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
27 April 2023
|
27 April 2028
|
| View |
|
DRP-13807
|
Gemcitabine (as hydrochloride)
|
Getanosan 200
|
200 mg
|
Powder for Solution for Injection (IV)
|
-
|
PT. Sanbe Farma (Unit 3)
|
Indonesia
|
Initial (Correction)
|
28 September 2023
|
26 April 2028
|
| View |
|
DRP-13714
|
Losartan Potassium + Hydrochlorothiazide
|
Biozart Plus 12.5
|
50 mg/12.5 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
26 April 2023
|
26 April 2028
|
| View |
|
DRP-13693
|
Fenofibrate
|
Dectri
|
160 mg
|
Tablet
|
-
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|