View |
|
DR-XY48508
|
Multivitamins + Zinc
|
ImmunACE Plus
|
Formulation
Each Softgel Capsule Contains:
Retinol Palmitate (Vitamin A) -3,000 IU
Ascorbic Acid (Vitamin C)-500 mg
Dl-a-Tocopheryl Acetate-100 IU
Pyridoxine Hydrochloride (Vitamin B6)-1.95 mg Zinc -25 mg
|
Softgel Capsule
|
-
|
Phil Inter Pharma Co., Ltd. (Plant 1)
|
Vietnam
|
Initial (OTC)
|
28 December 2022
|
28 December 2027
|
View |
|
DR-XY48509
|
Multivitamins
|
Enervon-C Filmcap
|
Formulation
Each Tablet Contains:
Ascorbic Acid (Vitamin C)
500 mg
Thiamine Mononitrate (Vitamin B1)
50 mg
Niacinamide (Vitamin B3)
50 mg
Calcium Pantothenate
20 mg
Riboflavin (Vitamin B2)
20 mg
Pyridoxine Hydrochloride (Vitamin B6)
5 mg
Cyanocobalamin (Vitamin B12)
5 mcg
|
Film-Coated Tablet
|
-
|
United International Pharma Co., Ltd.
|
India
|
Initial(OTC)
|
06 December 2022
|
06 December 2027
|
View |
|
DR-XY48510
|
Calcium Carbonate
|
Calci-Aid
|
1,250 mg (equivalent to 500 mg Calcium)
|
Softgel Capsule
|
-
|
Catalent Germany Eberbach GmbH
|
Germany
|
Initial
|
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 |
|
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-XY48514
|
Potassium Citrate
|
Noston
|
1.08g (10mEq)
|
Extended -Release Tablet
|
-
|
Eskayef Pharmaceuticals Limited
|
Bangladesh
|
Initial Correction]
|
19 January 2023
|
01 December 2027
|
View |
|
DR-XY48515
|
Oxycodone hydrochloride
|
Oxymarc
|
10 mg/mL
|
Solution for Injection/Infusion (IV/SC)
|
-
|
HBM Pharma S.R.O.
|
Slovak Republic
|
Initial
|
01 December 2022
|
01 December 2027
|
View |
|
DR-XY48516
|
Pregabalin
|
Regabin 75
|
75 mg
|
Capsule
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
01 December 2022
|
01 December 2027
|
View |
DR-XY48517_PI_01.pdf
|
DR-XY48517
|
Tolvaptan
|
Jinarc
|
15mg
|
Tablet
|
-
|
Otsuka Factor Pharmaceutical Co., Ltd. (Tokushima Itano Factory)
|
Japan
|
Monitored Release
|
01 December 2022
|
01 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 |
|
DR-XY48520
|
Clopidogrel (As Bisulfate) + Rosuvastatin (As Calcium)
|
None
|
75mg/20mg
|
Capsule
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
06 December 2022
|
06 December 2027
|
View |
|
DR-XY48521
|
Clopidogrel (As Bisulfate) + Rosuvastatin (as Calcium)
|
None
|
75mg/10mg
|
Capsule
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
06 December 2022
|
06 December 2027
|
View |
|
DR-XY48522
|
Levofloxacin
|
Levobest
|
500 mg
|
Film-Coated Tablet
|
-
|
Zhejiang Medicine Company Limited Xinchang Pharmaceutical Factory
|
China
|
Initial
|
07 December 2022
|
07 December 2027
|
View |
|
DR-XY48523
|
Olmesartan Medoxomil + Amlodipine (as Besilate)
|
Alzor CCB
|
40mg/10mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial (Correction)
|
23 January 2023
|
07 December 2025
|
View |
|
DR-XY48524
|
Telmisartan
|
None
|
80 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
09 December 2022
|
09 December 2027
|
View |
|
DR-XY48525
|
Vancomycin (As Hydrochloride)
|
Vancomarc
|
1g
|
Powder For I.V. Infusion
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
12 December 2022
|
12 December 2027
|
View |
|
DR-XY48526
|
Cefotaxime (as sodium)
|
Eotax-1000
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Zee Laboratories Limited
|
India
|
Initial
|
14 December 2022
|
14 December 2027
|
View |
|
DR-XY48527
|
Amiodarone Hydrochloride
|
Kabidarone
|
50 mg/mL
|
Solution For Injection (IV)
|
-
|
PT. Ethica Industri Farmasi (PT. Ethica)
|
Indonesia
|
Initial
|
14 December 2022
|
14 December 2027
|