| View |
|
DRP-3836-03
|
Betahistine hydrochloride
|
Allerway
|
16 mg
|
Film-Coated Tablet
|
-
|
J.M. Tolmann Laboratories Inc.
|
Philippines
|
Automatic Renewal
|
15 January 2024
|
09 December 2025
|
| View |
DR-XY48744_PI_01.pdf
|
DR-XY48744
|
Labetalol Hydrochloride
|
Betalex
|
5 mg/mL (20 mg/4 mL)
|
Solution for Injection (IV)
|
-
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
25 May 2023
|
25 May 2028
|
| View |
|
DR-XY13019
|
Morphine Sulfate
|
MST CONTINUS
|
30 mg
|
Modified-Release Tablet
|
-
|
Bard Pharmaceuticals Limited
|
United Kingdom
|
Automatic Renewal
|
25 September 2020
|
17 July 2025
|
| View |
|
DRP-11849-01
|
Dutasteride + Tamsulosin Hydrochloride
|
Tamduet
|
500 mcg/ 400 mcg
|
Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd
|
India
|
CLIDP Conversion
|
08 May 2023
|
10 May 2027
|
| View |
|
DRP-13352-01
|
Apixaban
|
Xavi
|
2.5 mg
|
Film Coated Tablet
|
-
|
Natco Pharma Limited (Unit IV and V)
|
India
|
CLIDP Conversion
|
10 April 2023
|
02 February 2028
|
| View |
|
DRP-14824
|
Meclizine hydrochloride
|
None
|
12.5 mg
|
Chewable Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial [OTC]
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14813
|
Erlotinib (as hydrochloride)
|
Erlonov
|
100 mg
|
Film-Coated Tablet
|
-
|
Laboratorio Eczane Pharma S.A.
|
Argentina
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14830
|
Hyoscine butylbromide + Paracetamol
|
Hyopan Plus
|
10 mg/500 mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRHR-2321
|
Methyl salicylate + Menthol + Camphor
|
Katinko (Ginger & Patchouli Scent)
|
20mg 20mg / 20mg per 1g
|
Ointment
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14825
|
Paracetamol + Thiamine (Vitamin B1) + Pyridoxine.
(Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
4Fever Plus
|
500 mg/50 mg/100 mg/100 mcg
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14826
|
Paracetamol + Thiamine (Vitamin B1) + Pyridoxine
(Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Tempmed Plus
|
500 mg/50 mg/100 mg/100 mcg
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14828
|
Sodium Bicarbonate
|
Bicarnate
|
650 mg
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14829
|
Sodium Bicarbonate
|
Bicarnate
|
325 mg
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14832
|
Paracetamol + Phenylephrine hydrochloride +
Chlorphenamine maleate + Zinc
|
Saphlozin
|
325 mg/10 mg / 2 mg/10 mg (equivalent to 27.5 mg
Zinc Sulfate Monohydrate)
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-144827
|
Paracetamol + Thiamine (Vitamin B1) + Pyridoxine (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Paraflex
|
500 mg/50 mg/100 mg/100 mcg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14822
|
Multivitamins + Minerals
|
Himeral
|
Formulation:
Each capsule contains:
Retinol Acetate (Vitamin A)
5000 IU
dl-Alpha Tocopheryl Acetate (Vitamin E)
100 IU
Ascorbic Acid (Vitamin C)
500 mg
Zinc (equivalent to 68.625 mg Zinc Sulfate Monohydrate)
25 mg
|
Capsule
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14821
|
Fusidic Acid
|
FuciskinTM
|
2% w/w
|
Topical Cream
|
-
|
East African (India) Overseas.
|
India
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14823
|
Multivitamins + Minerals
|
Efervit
|
Formulation:
Each capsule contains:
Ascorbic Acid (Vitamin C)
Calcium (eq. to 245.17 mg calcium carbonate and
23 mg calcium pantothenate)
Magnesium (eq. to 260.25 mg magnesium carbonate and 252.50 mg magnesium sulphate)
Nicotinamide (Vit. B3)
Pantothenic acid (Vit. Bs)
500 mg Riboflavin (Vit. B2)
100 mg Pyridoxine Hydrochloride (Vit. B6)
Zinc (eq. to 32 mg zinc citrate dihydrate)
100 mg Folic Acid
Biotin (Vit. H)
50 mg Cyanocobalamin (Vit. B12)
23 mg
Thiamine Hydrochloride (Vit. B1)
15 mg
15 mg 10 mg
10 mg
400 mcg
150 mcg
10 mcg
|
Effervescent Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
17 January 2024
|
17 January 2026
|
| View |
|
DR-XY48978
|
Zinc
|
Orezinc
|
20 mg (equivalent to 54.90 mg Zinc Sulfate Monohydrate) per 5 mL
|
Oral Solution
|
-
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DRP-14818
|
L-Alanyl-L-Glutamine
|
Glutarite
|
200 mg/mL
|
Solution for Intravenous (I.V.) Infusion
|
-
|
Aculife Healthcare Private Limited.
|
India
|
Initial
|
17 January 2024
|
17 January 2029
|