| View |
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DR-XY47544
|
Pregabalin
|
Neuroliz
|
75 mg
|
Capsule
|
-
|
Saga Laboratories
|
India
|
-
|
17 November 2021
|
17 November 2026
|
| View |
|
DR-XY47545
|
Moxifloxacin (As Hydrochloride)
|
Avelox
|
400 mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
Bayer Healthcare Manufacturing S.R.L.
|
Italy
|
Initial (Correction)
|
13 March 2024
|
18 November 2026
|
| View |
|
DR-XY47546
|
Multivitamins + Zinc + Copper
|
Stresstabs Energy Men
|
Formulation: Ascorbic Acid (Vitamin C)-300mg Niacinamide (Vitamin B3)-66mg
Thiamine Mononitrate (Vitamin B1)-33mg dl-Alpha Tocopheryl Acetate (Vitamin E)-30mg Riboflavin (Vitamin B2)-30mg Pantothenic Acid (as Calcium Pantothenate) (Vitamin B5)-20mg Pyridoxine HCl (Vitamin B6)-13.3mg Folic Acid (Vitamin B9)-300mcg Cyanocobalamin (Vitamin B12)-140mcg Biotin (Vitamin B7)-40mcg Lutein-600mcg Zinc (as Oxide)-15mg Copper (as Cupric Sulfate
Anhydrous)-500mcg
|
Film-Coated Tablet
|
-
|
Pfizer Biotech Corporation (Hsinchu Plant)
|
Taiwan
|
-
|
19 November 2021
|
19 November 2026
|
| View |
|
DR-XY47547
|
Progesterone
|
Utrogestan
|
100 mg
|
Oral Soft-gel Capsule
|
-
|
Cyndea Pharma S.L.
|
Spain
|
-
|
19 November 2021
|
19 November 2026
|
| View |
|
DR-XY47548
|
Progesterone
|
Utrogestan
|
200 mg
|
Vaginal Soft-gel Capsule
|
-
|
Cyndea Pharma S.L.
|
Spain
|
-
|
19 November 2021
|
19 November 2026
|
| View |
DR-XY47549_PI_01.pdf
|
DR-XY47549
|
Glycopyrronium (as bromide) + Formoterol fumarate
dihydrate
|
Bevespi Aerosphere
|
7.2 mcg/5 mcg per actuation
|
Pressurized Suspension
for Inhalation
|
-
|
AstraZeneca Dunkerque Production
|
France
|
-
|
19 November 2021
|
19 November 2026
|
| View |
|
DR-XY47550
|
Cefuroxime (As Sodium)
|
Globalfur
|
1.5 g
|
Powder for Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
-
|
19 November 2021
|
19 November 2026
|
| View |
|
DR-XY47551
|
Cefuroxime (As Sodium)
|
Globalfur
|
750 mg
|
Powder for Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
-
|
19 November 2021
|
19 November 2026
|
| View |
|
DR-XY47552
|
Azithromycin (as dihydrate)
|
Alzyl 500
|
500 mg
|
Film-Coated Tablet
|
-
|
Aurobindo Pharma Limited - Unit VII
|
India
|
Initial (Re-issuance)
|
16 August 2022
|
24 November 2026
|
| View |
|
DR-XY47553
|
Multivitamins + Minerals + Dimethylaminoethanol
(Deanol) + Royal Jelly + Panax ginseng (Korean
Panax Ginseng) Root Powder
|
Rogin-E
|
Formulation:
Each softgel capsule contains:
Retinyl Palmitate (Vit. A)
5000 IU Ergocalciferol (Vit. D2)
400 IU Calcium
90.7 mg dl-Alpha Tocopheryl Acetate (Vit. E) 75 mg Phosphorus
70 mg Ascorbic Acid Dimethylaminoethanol (Deanol) 30 mg
Panax ginseng (Korean Panax Ginseng) Root Powder 20 mg Riboflavin (Vit B2) Nicotinamide (Vit. B3)
20 mg
Thiamine HCI (Vit Bl) Calcium Pantothenate
10 mg Manganese Magnesium
5 mg
Zinc Royal Jelly
5 mg Cyanocobalamin (Vit B12) Potassium Pyridoxine HCI (Vit B6)
2 mg
1.5 mg 1.5 mg 1 mg 1 mg 3 mcg
60 mg
4 mg
|
Softgel Capsule
|
-
|
Catalent Germany Eberbach GmbH
|
Germany
|
-
|
19 November 2021
|
19 November 2026
|
| View |
|
DR-XY47554
|
Multivitamins + Minerals + Dimethylaminoethanol
(Deanol) + Royal Jelly + Panax ginseng (Korean
Panax Ginseng) Root Powder
|
Rogin-E
|
Not Applicable
|
Softgel Capsule
|
Vitamins/Minerals
|
Catalent Germany Eberbach GmbH
|
Germany
|
Initial
|
19 November 2021
|
19 November 2026
|
| View |
|
DR-XY47555
|
Levetiracetam
|
Logufen
|
250 mg
|
Film Coated Tablet
|
Antiepileptic
|
Kusum Healthcare Pvt., Ltd.
|
India
|
Initial
|
24 November 2021
|
24 November 2026
|
| View |
|
DR-XY47556
|
Silver Sulfadiazine
|
Sulfadex
|
10 mg/g (1%w/w)
|
Topical Cream
|
-
|
Dong Wha Pharm Co., Ltd.
|
Korea
|
-
|
22 November 2021
|
22 November 2026
|
| View |
|
DR-XY47557
|
Sodium Ascorbate + Zinc
|
Maxcee-Pro
|
500mg (equivalent to 562.5mg Sodium Ascorbate) /
10mg (equivalent to 27.5mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Lejal Laboratories, Inc.
|
Philippines
|
-
|
22 November 2021
|
22 November 2026
|
| View |
|
DR-XY47558
|
Mefenamic Acid
|
None
|
50 mg/5 mL
|
Oral Suspension (Banana and Peppermint
Flavor)
|
Non-Steroidal Anti-Inflammatory Drug (NSAID)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 November 2021
|
22 November 2026
|
| View |
|
DR-XY47559
|
Mefenamic Acid
|
None
|
50 mg/5 mL
|
Oral Suspension (Banana and Peppermint
Flavor)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
22 November 2021
|
22 November 2026
|
| View |
|
DR-XY47560
|
Mefenamic Acid
|
Ponser
|
50 mg/5 mL
|
Oral Suspension (Banana and Peppermint
Flavor)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
22 November 2021
|
22 November 2026
|
| View |
|
DR-XY47561
|
Ketotifen (As Fumarate)
|
Allernil
|
250 mcg/mL (0.025% w/v)
|
Ophthalmic Solution (Eye
Drops)
|
-
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
Initial (Re-issuance)
|
12 August 2022
|
23 November 2026
|
| View |
|
DR-XY47562
|
Celecoxib
|
Lecox-200
|
200 mg
|
Capsule
|
Non-steroidal Anti-inflammatory and Antirheumatic (Coxib)
|
Gracure Pharmaceutical Ltd.
|
India
|
Initial (Re-issuance)
|
04 August 2022
|
23 November 2026
|
| View |
|
DR-XY47563
|
Dexamethasone phosphate (as sodium)
|
Eodex
|
4 mg/mL (8 mg/2mL)
|
Solution for Injection
(I.V./I.M.)
|
-
|
Zee Laboratories Limited
|
India
|
Initial (re-issuance)
|
12 August 2022
|
23 November 2026
|