| View |
|
DR-XY47647
|
Cefriaxone (as sodium)
|
None
|
1g
|
Powder for Injection (IV Infusion)
|
-
|
Nipro Pharma Corporation Odate Plant
|
Japan
|
-
|
07 January 2022
|
07 January 2027
|
| View |
|
DRP-11048
|
Telmisartan
|
None
|
40 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
19 January 2022
|
19 January 2027
|
| View |
|
DRP-11049
|
Fusidic Acid
|
Fusirid
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antifungal
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial
|
19 January 2022
|
19 January 2027
|
| View |
|
DR-XY47646
|
Amoxicillin (as Trihydrate)
|
None
|
250mg
|
Capsule
|
-
|
Fortis Medi Pharmaceutical, Inc.
|
Philippines
|
-
|
07 January 2022
|
07 January 2027
|
| View |
|
DRP-11039
|
Citicoline
|
Citcole
|
500 mg
|
Film-Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
-
|
12 January 2022
|
12 January 2027
|
| View |
|
DR-XY47653
|
Atomoxetine (as hydrochloride)
|
Attentrol 40
|
40 mg
|
Capsule
|
Psychostimulant (Centrally Acting Sympathomimetic)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
07 January 2022
|
07 January 2027
|
| View |
|
DR-XY47655
|
Atomoxetine (as hydrochloride)
|
Attentrol 25
|
25 mg
|
Capsule
|
Psychostimulant (Centrally Acting Sympathomimetic)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
07 January 2022
|
07 January 2027
|
| View |
|
DR-XY47654
|
Atomoxetine (as hydrochloride)
|
Attentrol 18
|
18 mg
|
Capsule
|
Psychostimulant (Centrally Acting Sympathomimetic)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
07 January 2022
|
07 January 2027
|
| View |
|
DR-XY47650
|
Alfuzosin hydrochloride
|
Adzosin
|
10 mg
|
Sustained-Release Tablets
|
Alpha-adrenoreceptor antagonist
|
Aurobindo Pharma Limited - Unit III
|
India
|
Initial
|
19 January 2022
|
19 January 2027
|
| View |
|
DR-XY47652
|
Eugenol
|
None
|
1 mg/mL
|
Solution (Toothache Drops)
|
-
|
Vonwelt, Inc.
|
Philippines
|
-
|
06 January 2022
|
06 January 2027
|
| View |
DR-XY47680_PI_01.pdf
|
DR-XY47680
|
Fosphenytoin Sodium
|
Aurantin
|
75 mg/mL Solution for Injection (I.M./I.V.) [equivalent to Phenytoin sodium 50 mg/mL after
administration]
|
Solution For Injection (IM/IV)
|
Antiepiletic (Hydantoin Derivative)
|
Pharmacia and Upjohn Company LLC
|
United States of America
|
Monitored Release (Compliance)
|
20 January 2022
|
20 January 2027
|
| View |
|
DRP-11100
|
Tenoxicam
|
Ostenox
|
20 mg
|
Lyophilized Powder For Injection (IM/IV)
|
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
|
Anfarm Hellas S.A.
|
Greece
|
Monitored Release
|
28 January 2022
|
28 January 2027
|
| View |
|
DR-XY47656
|
Oxaliplatin
|
Platinox
|
100 mg
|
Lyophilized Powder For Injection (I.V. Infusion)
|
-
|
Korea United Pharm. Inc.
|
Korea
|
-
|
07 January 2022
|
07 January 2027
|
| View |
|
DR-XY47030
|
Cefuroxime (as sodium)
|
Teroxime
|
1.5 g
|
Powder For Injection
|
Antibacterial (Cephalosporin)
|
Sance Laboratories Pvt.Ltd.
|
India
|
Monitored Release
|
11 January 2022
|
11 January 2027
|
| View |
|
DRP-11044
|
Potassium Citrate
|
Cytrakon
|
1080 mg
|
Extended Release Tablet
|
Antiurolithic
|
MAGBRO HEALTHCARE PVT. LTD.
|
India
|
Initial
|
18 January 2022
|
18 January 2027
|
| View |
|
DRP-11068
|
Amiodarone (As Hydrochloride)
|
Tachyrone
|
50 mg/mL (150 mg/3 mL)
|
Solution for Injection (I.V.)
|
Antiarrhythmic
|
Gland Pharma Limited
|
India
|
Initial
|
21 January 2022
|
21 January 2027
|
| View |
|
DR-XY47681
|
Cefpodoxime (As Proxetil)
|
Cefpo-200
|
200 mg
|
Tablet
|
Antibacterial (Cephalosporin)
|
Oman Pharmaceutical Products Co., LLC
|
Oman
|
Initial
|
21 January 2022
|
21 January 2027
|
| View |
|
DR-XY47682
|
Exemestane
|
Zymestan
|
25 mg
|
Tablet
|
Aromatase Inhibitor
|
Oman Pharmaceutical Products Co., LLC
|
Oman
|
Initial
|
21 January 2022
|
21 January 2027
|
| View |
|
DR-XY47658
|
Ticagrelor
|
Agraplat
|
90 mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
-
|
10 January 2022
|
10 January 2027
|
| View |
|
DRP-10863
|
Ketorolac Tromethamine
|
Bellurak
|
30 mg/mL
|
Solution For Injection (I.M./I.V.)
|
Nonsteroidal Anti-Inflammatory Drug
|
PT. Phapros Tbk
|
Indonesia
|
Initial
|
19 January 2022
|
19 January 2027
|