| View |
|
DRP-13135
|
Ascorbic Acid+Zinc+Cholecalciferol
|
Corzinc Plus
|
500mg/30mg/1000IU
|
Capsule
|
-
|
Drugmaker's Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
06 December 2022
|
06 December 2024
|
| View |
|
DR-XY48514
|
Potassium Citrate
|
Noston
|
1.08g (10mEq)
|
Extended -Release Tablet
|
-
|
Eskayef Pharmaceuticals Limited
|
Bangladesh
|
Initial Correction]
|
19 January 2023
|
01 December 2027
|
| View |
|
DR-XY48516
|
Pregabalin
|
Regabin 75
|
75 mg
|
Capsule
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
|
DRP-13126
|
Pregabalin
|
Prebasit
|
75 mg
|
Capsule
|
-
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
05 December 2022
|
05 December 2027
|
| View |
|
DRP-13129
|
Meropenem (as Trihydrate)
|
Carpenem-1000
|
1 g
|
Powder For Injection (I.V.)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 December 2022
|
05 December 2027
|
| View |
|
DRP-13128
|
Meropenem (as Trihydrate)
|
Carpenem-500
|
500 mg
|
Powder For Injection (I.V.)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 December 2022
|
05 December 2027
|
| View |
|
DRP-13104
|
Vancomycin (as Hydrochloride)
|
Vancolite 1000
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
|
DRP-13105
|
Vancomycin (as Hydrochloride)
|
Vancolite 500
|
500mg
|
Powder for Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
|
DRP-13025
|
Salmeterol (as xinafoate) + Fluticasone propionate
|
Fluticasal
|
25 mcg/ 250 mcg per actuation
|
Metered Dose Inhaler
|
-
|
World Medicine İlaç Sanayi Ve Ticaret A.Ş.
|
Turkey
|
Initial (Correction)
|
28 December 2022
|
29 November 2027
|
| View |
|
DR-XY48513 (For Export Only)
|
Guaifenesin
|
Robitussin EX
|
200mg/10mL
|
Syrup
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
01 December 2022
|
01 December 2027
|
| View |
|
DR-XY48511
|
Eucalyptus Oil + Dementholized Mint Oil (Mentha arvensis) Cajuput Oil (Melaleuca leucadendra) + Menthol Crystal + Methyl Salicylate + Juniperberry Oil (Juniperus communis) + Clove Bud Oil (Syzygium aromaticum)
|
Purekids Ido Lemon
|
Formulation:
Each 10 mL contains:
Eucalyptus Oil-877 mg
Dementholised Mint Oil-877mg
Cajuput Oil-458mg
Menthol Crystal-101mg
Methyl Salicylate-92mg
Juniperberry Oil-67mg Clove Bud Oil-
2.4 mg
|
Liniment Oil (Lemon
Scent)
|
-
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
05 December 2022
|
05 December 2027
|
| View |
|
DR-XY48512
|
Eucalyptus Oil+ Dementholized Mint Oil (Mentha arvensis) Cajuput Oil (Melaleuca leucadendra) + Menthol Crystal Methyl Salicylate + Juniperberry
Oil (Juniperus communis) + Clove Bud Oil (Syzygium aromaticum)
|
Purekids Ido Geranium
|
Formulation:
Each 10 mL contains:
Eucalyptus Oil -877 mg
Dementholised Mint Oil-877mg
Cajuput Oil-458mg
Menthol Crystal-101mg
Methyl Salicylate-92mg
Juniperberry Oil-67mg Clove Bud Oil-2.4mg
|
Liniment Oil (Geranium
Scent)
|
-
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
05 December 2022
|
05 December 2027
|
| View |
|
DRP-13114
|
Ascorbic Acid + Cholecalciferol (Vitamin D3) + Zinc
|
Imun Z+
|
Formulation:
Each capsule contains:
Ascorbic Acid..500mg .
Cholecalciferol (Vitamin D3)........1000IU
Zinc......... 10mg
(equivalent to 71.42 mg Zinc Gluconate)
|
Capsule
|
-
|
Skylark Pharmaceuticals Pvt. Ltd.
|
India
|
Initial [OTC]
|
02 December 2022
|
02 December 2027
|
| View |
|
DR-XY48518
|
Bisacodyl
|
Rapcodyl
|
5 mg
|
Delayed Release Enteric Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
05 December 2022
|
05 December 2027
|
| View |
|
DR-XY48519
|
Bisacodyl
|
Dulcogen
|
5 mg
|
Delayed Release Enteric Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
05 December 2022
|
05 December 2027
|
| View |
|
DRP-13112
|
Diosmin + Hesperidin
|
Venoright Forte
|
900 mg / 100 mg
|
Film-Coated Tablet
|
-
|
Novagen Healthcare Private Limited
|
India
|
Initial (OTC) correction
|
31 January 2023
|
02 December 2027
|
| View |
DRP-13122_PI_01.pdf
|
DRP-13122
|
Levetiracetam
|
None
|
100 mg/mL (500 mg/5 mL)
|
Concentrate Solution For Infusion (IV)
|
-
|
Beijing Sciecure Pharmaceutical Co., Ltd.
|
China
|
Initial (Reapplication)
|
05 December 2022
|
05 December 2027
|
| View |
|
DRHR-1309
|
Folic Acid
|
Farafol
|
5 mg
|
Tablet
|
-
|
Maxtar Bio-GenicsERT
|
India
|
Initial (OTC)
|
01 December 2022
|
01 December 2027
|
| View |
|
DRP-13127
|
Ketoanalogues + Essential Amino Acids
|
Ketoxam
|
(See Reverse for Unit Dose Formulation)
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial (Reconstruction)
|
18 January 2024
|
05 December 2027
|
| View |
|
DRP-13064
|
Betamethasone Valerate + Neomycin Sulfate
|
Betaneosaph
|
1 mg/ 5 mg per gram (0.1% w/w / 0.5 w/w)
|
Topical Cream
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
01 December 2022
|
01 December 2027
|