| View |
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DRP-13495
|
Dextromethorphan Hydrobromide + Guaifenesin +
Phenylephrine Hydrochloride
|
Exicof
|
30mg/200mg/10mg per 10mL
|
Syrup (Menthol Flavor)
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
28 February 2023
|
28 February 2028
|
| View |
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DRP-13496
|
Dextromethorphan Hydrobromide + Guaifenesin + Phenylephrine Hydrochloride
|
Exicof
|
30mg/200mg/10mg per 10mL
|
Syrup (Menthol -
Strawberry Flavor)
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
28 February 2023
|
28 February 2028
|
| View |
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DR-XY48627
|
Multivitamins + Minerals
|
Nutribone
|
Formulation
Each Film-Coated Tablet:
Ascorbic Acid (Vitamin C) 60 mg
Colecalciferol (Vitamin D3) 200 IU
Dl-alpha-Tocopheryl Acetate (Vitamin E) 15 IU
Boron Citrate 250 mcg
Calcium (as Calcium Carbonate) 600 mg
Copper (as Cupric Oxide) 1 mg
Magnesium 20 mg
Manganese (as sulfate monohydrate) 1 mg
Zinc (as Zinc Oxide) 7.5 mg
|
Film-Coated Tablet
|
-
|
The ACME Laboratories Limited
|
Bangladesh
|
Initial
|
28 February 2023
|
28 February 2028
|
| View |
|
DRP-13480
|
Epirubicin (as hydrochloride)
|
Sanzepir-50
|
50mg
|
Lyophilized Powder for Injection (IV)
|
-
|
Admac Lifesciences
|
India
|
Initial
|
27 February 2023
|
27 February 2028
|
| View |
|
HRP-567
|
Isopropyl Alcohol
|
Alco-Aid
|
70% (v/v)
|
Solution
|
-
|
Primecare Lifesciences Laboratories Corp.
|
Philippines
|
Initial (OTC)
|
27 February 2023
|
27 February 2028
|
| View |
|
HRP-568
|
Isopropyl Alcohol
|
Alco-Aid
|
70% (v/v)
|
Solution
|
-
|
Primecare Lifesciences Laboratories Corp.
|
Philippines
|
Initial (OTC)
|
27 February 2023
|
27 February 2028
|
| View |
|
DRP-13481
|
Bupivacaine (as hydrochloride) w/ Dextrose
|
Bupivasaph-D
|
5 mg/mL
|
Solution for Injection (Intrathecal)
|
Local Anesthetic
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial (Correction)
|
18 June 2024
|
23 February 2028
|
| View |
|
DRP-13486
|
Metronidazole
|
None
|
5 mg/mL (500 mg/100 mL)
|
Solution for Injection
(IV Infusion)
|
-
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 February 2023
|
27 February 2028
|
| View |
|
DRP-13465
|
Metformin hydrochloride
|
Medformin-500
|
500mg
|
Film Coated Tablet
|
-
|
Acme Formulation Pvt. Ltd.
|
India
|
Initial (Re-application)
|
23 February 2023
|
23 February 2028
|
| View |
|
DRHR-2209
|
Methyl Salicylate + Menthol + Camphor
|
Katinko Calming
|
2 g/2 g/2 g per 100 g
|
Ointment (Lavender Scent)
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
27 February 2023
|
27 February 2028
|
| View |
|
DRHR-2208
|
Methyl Salicylate + Menthol + Camphor
|
Katinko Lavender
|
2 g/ 2 g/ 2g per 100 g
|
Ointment Stick (Lavender Scent)
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
27 February 2023
|
27 February 2028
|
| View |
|
DR-XY44027
|
Losartan Potassium + Amlodipine (as Besilate)
|
Amlobloc Duo
|
50 mg/5 mg
|
Film-Coated Tablet
|
-
|
Rhydbu Pharmaceuticals Limited
|
India
|
PCPR/Automatic Renewal (Reconstruction)
|
13 October 2023
|
12 January 2025
|
| View |
|
DRP-12481
|
Tobramycin (as sulfate)
|
Novamycin
|
3 mg/mL (0.3% w/v)
|
Ophthalmic Solution (Eye Drops).
|
-
|
Pharmacos Exakta, S.A. De C.V
|
Mexico
|
DRP-12481
|
03 March 2023
|
03 March 2028
|
| View |
|
DRP-13523
|
Losartan potassium + Amlodipine (as besilate)
|
Lopinov
|
50 mg/5 mg
|
Film-Coated Tablet
|
-
|
Unison Pharmaceuticals Pvt. Ltd. (Unit I)
|
India
|
DRP-13523
|
03 March 2023
|
03 March 2028
|
| View |
|
DRP-13541
|
Pregabalin
|
None
|
75mg
|
Capsule
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
DRP-13541
|
08 March 2023
|
08 March 2028
|
| View |
|
DRP-13542
|
Pregabalin
|
None
|
50mg
|
Capsule
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
DRP-13542
|
08 March 2023
|
08 March 2028
|
| View |
|
DRP-13540
|
Pregabalin
|
None
|
150mg
|
Capsule
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
DRP-13540
|
08 March 2023
|
08 March 2028
|
| View |
|
DRP-13532
|
Epirubicin Hydrochloride
|
Rubifon
|
2 mg/mL (10 mg/5 mL)
|
Concentrate solution for
Injection (IV/Intravesical)
|
-
|
PT. Fonko International Pharmaceuticals
|
Indonesia
|
DRP-13532
|
08 March 2023
|
08 March 2028
|
| View |
|
DRP-13531
|
Epirubicin Hydrochloride
|
Rubifon
|
2 mg/mL (50 mg/25 mL)
|
Concentrate solution for
Injection (IV/Intravesical)
|
-
|
PT. Fonko International Pharmaceuticals
|
Indonesia
|
DRP-13531
|
08 March 2023
|
08 March 2028
|
| View |
|
DRP-13522
|
Docetaxel (as trihydrate)
|
Chetax-80
|
40 mg/mL (80 mg/2 mL)
|
Concentrate Solution for IV
Infusion
|
Antineoplastic (Taxane)
|
Admac Lifesciences
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
03 March 2028
|