| View |
|
DRP-11913
|
Escitalopram (as Oxalate)
|
Depram
|
20 mg
|
Film Coated Tablet
|
Antidepressant (Selective Serotonin Reuptaki Inhibitor)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
20 May 2022
|
20 May 2027
|
| View |
|
DR-XY48017
|
Deflazacort
|
Defal
|
30 mg
|
Tablet
|
-
|
Faes Farma, S.A.
|
Spain
|
Monitored Release
|
16 May 2022
|
16 May 2025
|
| View |
|
DR-XY48023
|
Celecoxib
|
Celodix-200
|
200mg
|
Capsule
|
-
|
Zim Laboratories Limited
|
India
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DRP-11871
|
Tadalafil
|
Excia
|
20mg
|
Film-Coated Tablet
|
Phosphodiesterase Type-5 Inhibitor
|
Corona Remedies Private Limited
|
India
|
Initial
|
16 May 2022
|
16 May 2027
|
| View |
|
DRP-11928
|
Cefuroxime (as Sodium)
|
Cefuhil
|
750mg
|
Powder For Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
20 May 2022
|
20 May 2027
|
| View |
|
DRP-11899
|
Diclofenac Sodium
|
Dyclo
|
25 mg/mL
|
Solution For Injection (IM/IV)
|
Non-steroidal Anti-inflammatory Drug (NSAID)
|
Indus Pharma (Pvt.) Ltd.
|
Pakistan
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DRP-11923
|
Standardized Senna Concentrate
|
None
|
187 mg (equivalent to 8.6 mg Sennosides)
|
Film-coated Tablet
|
Laxative
|
Diamond Laboratories Inc.
|
Philippines
|
Initial
|
20 May 2022
|
20 May 2027
|
| View |
|
DRP-11889
|
Cefazolin (As Sodium)
|
Novazolin
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DRP-11907
|
Vancomycin (As Hydrochloride)
|
Myreskib
|
500 mg
|
Lyophilized Powder for Injection (I.V.)
|
Antibacterial (Glycopeptide)
|
Mylan Laboratories Limited [Specialty Formulation Facility]
|
India
|
Initial [Rx]
|
19 May 2022
|
19 May 2027
|
| View |
|
DRP-11902
|
Salbutamol (as Sulfate)
|
Salbunova
|
1 mg/mL (2.5 mg/2.5 mL)
|
Solution for Inhalation
|
Selective Beta-2-Adrenoceptor Agonist
|
Ahlcon Parenterals (India) Limited
|
India
|
Initial
|
19 May 2022
|
19 May 2027
|
| View |
|
DRP-11832
|
Pramipexole (as dihydrochloride monohydrate)
|
Prepexol
|
700 mcg
|
Tablet
|
Anti-Parkinson (Dopamine agonist)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
13 May 2022
|
13 May 2027
|
| View |
|
DRP-11900
|
Dicycloverine Hydrochoride
|
Relestal
|
5 mg/mL
|
Syrup (Oral Drops)
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Automatic Renewal (Variation ; PCPR Conversion)
|
18 May 2022
|
20 November 2025
|
| View |
|
DRP-11901
|
Dicycloverine Hydrochoride
|
Relestal
|
10 mg/5 mL
|
Syrup
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Automatic Renewal (Variation ; PCPR Conversion)
|
18 May 2022
|
20 November 2025
|
| View |
|
DRP-11888
|
Dorzolamide + Timolol
|
None
|
20 mg/5 mg per mL (2% w/v / 0.5% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Antiglaucoma
|
Indoco Private Remedies
|
India
|
Initial
|
17 May 2022
|
17 May 2025
|
| View |
|
DRP-11887
|
Dorzolamide + Timolol
|
Combidor
|
20 mg/5 mg per mL (2% w/v / 0.5% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Antiglaucoma
|
Indoco Private Remedies
|
India
|
Initial (Rx]
|
17 May 2022
|
17 May 2025
|
| View |
|
DRP-11904
|
Irbesartan
|
Irbenov-300
|
300mg
|
Film Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Macleods Pharmaceuticals Limited (Unit II)
|
India
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DRP-11910
|
Ibandronic acid
|
Ibandren
|
150 mg
|
Film-Coated Tablet
|
Bisphosphonate
|
Theragen Etex Co., Ltd.
|
Korea
|
Initial (Reconstruction)
|
06 February 2024
|
19 May 2027
|
| View |
|
DRP-11822
|
Levofloxacin(As Hemihydrate)
|
None
|
5 mg/mL (500 mg/100 mL)
|
Solution for IV Infusion
|
Antibacterial (Fluoroquinolone)
|
Ahlcon Parenterals (India) Limited
|
India
|
Initial
|
16 May 2022
|
16 May 2027
|
| View |
|
DRP-11896
|
Budesonide + Formoterol Fumarate Dihydrate
|
Rolastym Combi
|
400 mcg / 12 mcg
|
Dry Powder for Inhalation in Capsule
|
Adrenergic-Corticosteroid Combination
|
Deva Holding A.Ş Çerkezköy I
|
Turkey
|
Monitored Release
|
17 May 2022
|
17 May 2027
|
| View |
|
DR-XY48019
|
Esmolol Hydrochloride
|
Esmobloc
|
10 mg/mL (2.5 g/250 mL)
|
Solution for Injection (IV)
|
Selective Beta Blocking Agent
|
Polifarma Ilaç San. Ve Tic. A.S.
|
Turkey
|
Initial
|
18 May 2022
|
18 May 2027
|