| View |
|
DR-XY47714
|
Sultamicillin tosilate
|
Zunamyn
|
750 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-Lactamase Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
09 February 2022
|
09 February 2027
|
| View |
|
DR-XY47715
|
Ascorbic Acid + Zinc
|
None
|
Formulation:
Each mL contains:
Ascorbic Acid..................23.75 Ascorbic Acid (equivalent to 28.61 mg Zinc Ascorbate)..............21.25 Zinc (equivalent to 28.61 mg Zinc Ascorbate).................4.5 mg
|
Syrup (Oral Drops) (Orange Flavor)
|
Vitamin/Mineral
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 February 2022
|
08 February 2027
|
| View |
|
DR-XY47716
|
Vancomycin (as hydrochloride)
|
Vancocyn
|
500 mg
|
Powder for Injection (IV)
|
Antibacterial (Glycopeptide)
|
Karnataka Antibiotics & Pharma Ltd.
|
India
|
Initial
|
02 March 2022
|
02 March 2027
|
| View |
|
DR-XY47717
|
Ascorbic Acid + Zinc + Colecalciferol (Vitamin D3)
|
Immunforte
|
500mg (equivalent to 562.43mg Sodium Ascorbate /
| 10mg (equivalent to 27.5mg Zinc Sulfate Monohydrate /
1000 IU
|
Film-Coated Tablet
|
Vitamins / Mineral
|
UNILAB, Inc.
|
Philippines
|
Initial (OTC) correction
|
06 June 2022
|
09 February 2027
|
| View |
|
DR-XY47718
|
Meropenem
|
Eopenem
|
1 g
|
Powder For Injection (IV)
|
Antibacterial (Carbapenem)
|
Zee Laboratories Limited
|
India
|
Initial
|
10 February 2022
|
10 February 2027
|
| View |
|
DR-XY47719
|
Gemcitabine (as hydrochloride)
|
Gemhexin
|
1 g
|
Lyophilized Powder for Injection (IV Infusion)
|
Antineoplastic (Pyrimidine Analogue)
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
10 February 2022
|
10 February 2027
|
| View |
DR-XY47720_PI_01.pdf
|
DR-XY47720
|
Zinc (as gluconate)
|
None
|
1mg/ mL
|
Concentrate for Solution for I.V. Infusion
|
Mineral Supplement
|
Laboratoire Aguettant
|
France
|
Monitored Release
|
11 February 2022
|
11 February 2027
|
| View |
|
DR-XY47721
|
Teicoplanin
|
Vellanin
|
400 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Glycopeptide Antibacterial)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Monitored Release
|
11 February 2022
|
11 February 2027
|
| View |
|
DR-XY47722
|
Cefpodoxime (as Proxetil)
|
Cefpo-100
|
100 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Oman Pharmaceutical Products Co., LLC
|
Oman
|
Initial
|
10 February 2022
|
10 February 2027
|
| View |
|
DR-XY47723
|
Nebivolol (as hydrochloride) + Amlodipine (as besilate)
|
Nebilong -AM
|
5mg/ 5mg
|
Tablet
|
Beta Blocker-Calcium Channel Blocker Combination
|
Micro Labs Limited
|
India
|
Monitored Release
|
11 February 2022
|
11 February 2027
|
| View |
DR-XY47724_PI_01.pdf
|
DR-XY47724
|
Luseogliflozin (as hydrate)
|
Luseco
|
5 mg
|
Film-Coated Tablet
|
-
|
Taisho Pharmaceutical Co., Ltd. (Omiya Factory)
|
Japan
|
-
|
11 February 2022
|
11 February 2025
|
| View |
DR-XY47725_PI_01.pdf
|
DR-XY47725
|
Luseogliflozin (as hydrate)
|
Luseco
|
2.5 mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug [Sodium-Glucose Co
Transporter 2 (SGLT2) Inhibitor]
|
Taisho Pharmaceutical Co., Ltd. (Omiya Factory)
|
Japan
|
Monitored Release
|
11 February 2022
|
11 February 2025
|
| View |
|
DR-XY47726
|
Menthol + Glycyrrhiza glabra (Liquorice) Root +
Zingiber officinale (Ginger) Rhizome + Phyllantus
emblica (Indian Gooseberry) Fruit
|
Vicks Vapo Drops
|
7mg/15mg/10mg/10mg
|
Lozenge (Orange Menthol
Flavor)
|
-
|
Unique Pharmaceutical Laboratories (Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
India
|
-
|
11 February 2022
|
11 February 2027
|
| View |
|
DR-XY47727
|
Menthol + Glycyrrhiza glabra (Liquorice) Root +
Zingiber officinale (Ginger) Rhizome + Phyllantus
emblica (Indian Gooseberry) Fruit
|
Vicks VapoDrops
|
7mg/15mg/10mg/10mg Lozenge (Honey Lemon
Menthol Flavor)
|
Lozenges
|
-
|
Unique Pharmaceutical Laboratories (Division of J.B. Chemicals & Pharmaceuticals Ltd.)
|
India
|
-
|
11 February 2022
|
11 February 2027
|
| View |
|
DR-XY47728
|
Cholecalciferol (Vitamin D3)
|
None
|
2000 IU
|
Softgel Capsule
|
Vitamin
|
Phil Inter Pharma Co., Ltd. (Plant 1)
|
Vietnam
|
Initial
|
15 February 2022
|
15 February 2027
|
| View |
|
DR-XY47729
|
Pancreatin
|
Enzystal P
|
116 mg
|
Enteric-Coated Tablet
|
Digestive Enzyme
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial (Correction)
|
01 April 2022
|
15 February 2027
|
| View |
|
DR-XY47730
|
Ascorbic Acid + dl-Alpha Tocopheryl Acetate
(Vitamin E)
|
Pure-Cee'E
|
110 mg (equivalent to 123.73 mg Sodium
Ascorbate)/24 IU
|
Capsule
|
Vitamins
|
Growrich Manufacturing Inc.
|
Philippines
|
Initial
|
15 February 2022
|
15 February 2027
|
| View |
|
DR-XY47731
|
Aluminum Hydroxide + Magnesium Hydroxide + Simethicone
|
Kremil-S Cool Relief
|
356 mg/466 mg/20 mg per 20 mL
|
Suspension
(Menthol Flavor)
|
Antacid/Antiflatulent
|
United International Pharma Co., Ltd
|
Vietnam
|
Initial
|
17 February 2022
|
17 February 2027
|
| View |
DR-XY47732_PIL_01.pdf
|
DR-XY47732
|
Ascorbic Acid + Zinc
|
Zorb8 Forte
|
890mg (equivalent to 1000mg Sodium Ascorbate) / 25 mg (equivalent to 69mg Zinc Sulfate Monohydrate)
|
Tablet
|
Vitamin/Mineral
|
Compact Pharmaceuticals, Corp.
|
Philippines
|
Initial
|
16 February 2022
|
16 February 2027
|
| View |
|
DR-XY47733
|
Famciclovir
|
Herpex Newgen
|
250 mg
|
Film-Coated Tablet
|
Antiviral (Nucleoside/Nucleotide)
|
Korea United Pharm. Inc.
|
Korea
|
Monitored Release
|
16 February 2022
|
16 February 2027
|