| View |
DR-XY47500_PI_01.pdf
|
DR-XY47500
|
Teneligliptin (as hydrobromide hydrate + Pioglitazone (Hydrochloride)
|
Tenelizone
|
20mg/ 15mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drugs (Thiazolidinedione)
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
24 December 2021
|
27 October 2026
|
| View |
|
DR-XY47501
|
Co-amoxiclav
|
Aclav-625
|
625 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin and Beta-lactamase
inhibitor)
|
M.K. Pharma Pvt. Ltd.
|
India
|
Initial (Compliance)
|
29 October 2021
|
29 October 2026
|
| View |
|
DR-XY47502
|
Ascorbic Acid + Zinc
|
Zimmunity
|
500 mg (equivalent to 565.50 mg Sodium Ascorbate)
/10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Compact Pharmaceuticals, Corp.
|
Philippines
|
-
|
09 February 2022
|
29 October 2026
|
| View |
|
DR-XY47503
|
Betamethasone (as Valerate)
|
Betaderm
|
1 mg/g (0.1% w/w)
|
Topical Cream
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
29 October 2021
|
29 October 2026
|
| View |
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DR-XY47504
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Pizoba 4.5
|
4g/ 500mg
|
Powder for Injection (IV)
|
-
|
MDC Exports Pvt., Ltd.
|
India
|
-
|
29 October 2021
|
29 October 2026
|
| View |
|
DR-XY47505
|
Methotrexate
|
Metoxate
|
25 mg/mL (50 mg/2mL)
|
Solution for Injection
(I.M./I.V.)
|
-
|
Ildong Pharmaceutical Co., Ltd.
|
Korea
|
-
|
29 October 2021
|
29 October 2026
|
| View |
|
DR-XY47506
|
Cabazitaxel
|
Cabazred
|
60 mg/ 1.5 mL
|
Concentrate Solution for I.V. Infusion
|
Antineoplastic Agent (Taxane)
|
Dr. Reddy's Laboratories Ltd. (Formulation Unit 7)
|
India
|
Initial
|
29 October 2021
|
29 October 2024
|
| View |
|
DR-XY47507
|
Paracetamol
|
Leniol
|
1 g/ 100 ml
|
Solution for IV Infusion
|
Analgesic/ Antipyretic
|
Otsuka Pharmaceutical India Private Limited
|
India
|
Initial
|
15 March 2022
|
15 March 2027
|
| View |
|
DR-XY47508
|
Gabapentin
|
None
|
300 mg
|
Capsule
|
-
|
Korea United Pharm, Int'l JSC
|
Vietnam
|
-
|
02 December 2021
|
02 December 2026
|
| View |
|
DR-XY47509
|
Metronidazole (As Benzoate)
|
Berrydazole
|
250 mg/5mL
|
Oral Suspension
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
03 November 2021
|
03 November 2024
|
| View |
|
DR-XY47510
|
Ascorbic Aci
|
None
|
500 mg (equivalent to 568.18 mg Sodium Ascorbate)
|
Capsule
|
-
|
Northfield Laboratories Inc.
|
Philippines
|
-
|
04 November 2021
|
04 November 2026
|
| View |
|
DR-XY47511
|
Esomeprazole (as sodium)
|
Genium
|
40 mg
|
Lyophilized Powder for I.V. Infusion
|
Proton Pump Inhibitor
|
Gen İlaç VE Sağlik Ürünleri San. Ve Tic. Aş.
|
Turkey
|
Initial
|
04 November 2021
|
04 November 2026
|
| View |
|
DR-XY47512
|
Maxxi Nerve
|
Multivitamins
|
Formulation Thiamine Mononitrate (Vitamin B1) Pyridoxine Hydrochloride (Vitamin B6) Cyanocobalamin (Vitamin B12) dl-Alpha Tocopheryl Acetate (Vitamin E)
300mg 100mg
1mg
200mg
|
Film-Coated Tablet
|
-
|
J.M. Tolmann Laboratories Inc.
|
Philippines
|
-
|
04 November 2021
|
04 November 2026
|
| View |
|
DR-XY47513
|
Ivabradine (as hydrochloride)
|
None
|
5 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
17 November 2021
|
17 November 2026
|
| View |
|
DR-XY47514
|
Vitamin B1 + Vitamin B6 + Vitamin B12
+ Buclizine Hydrochloride + Lysine Hydrochloride
|
Appebon
|
formulation Each mL Syrup contains:
Thiamine Hydrochloride (Vitamin B1) Pyridoxine Hydrochloride (Vitamin B6) Cyanocobalamin (Vitamin B12) Buclizine Hydrochloride Lysine Hydrochloride
mg mcg
25
mg
300
mg
|
Syrup
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
05 November 2020
|
05 November 2026
|
| View |
DR-XY47515_PI_01.pdf
|
DR-XY47515
|
Dexmedetomidine (as hydrochloride) in 0.9% w/v
Sodium Chloride
|
Precedex Premix
|
4 mcg/mL
|
Solution for Intravenous Infusion
|
Hypnotic/Sedative
|
Hospira, Inc.
|
United States of America
|
Monitored Release
|
05 November 2021
|
05 November 2026
|
| View |
|
DR-XY47516
|
Ezetimibe + Rosuvastatin (as calcium)
|
Rosuzet
|
10 mg/5 mg
|
Film-Coated Tablet
|
-
|
Hanmi Pharmaceutical Co., Ltd.
|
Korea
|
-
|
05 November 2021
|
05 November 2024
|
| View |
|
DR-XY47517
|
Ezetimibe + Rosuvastatin (as calcium)
|
Rosuzet
|
10 mg/10 mg
|
Film-Coated Tablet
|
-
|
Hanmi Pharmaceutical Co., Ltd.
|
Korea
|
-
|
05 November 2021
|
05 November 2024
|
| View |
|
DR-XY47518
|
Ezetimibe + Rosuvastatin (As Calcium)
|
Rosuzet
|
10 mg/20 mg
|
Film-Coated Tablet
|
-
|
Hanmi Pharmaceutical Co., Ltd.
|
Korea
|
-
|
05 November 2021
|
05 November 2024
|
| View |
|
DR-XY47519
|
Ceftriaxone (as sodium) + Sulbactam (as sodium)
|
Xefatrex
|
1 g/500 mg
|
Powder for Injection (I.M./I.V.)
|
-
|
Theon Pharmaceuticals Limited
|
India
|
-
|
08 November 2021
|
08 November 2026
|