| View |
|
DRP-13530
|
Etoricoxib
|
Etoxiv-120
|
120 mg
|
Film Coated Tablet
|
-
|
Celogen Generics Private Ltd.
|
India
|
Initial
|
08 March 2023
|
08 March 2028
|
| View |
|
DR-XY48640
|
Docetaxel
|
Brexel 20
|
20 mg/2 mL
|
Solution for IV Injection
|
-
|
PT. Global Onkolab Farma
|
Indonesia
|
Initial
|
07 March 2023
|
07 March 2025
|
| View |
|
DRP-13502
|
Quetiapine (As Fumarate)
|
Qutero 100
|
100mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
DRP-13502
|
28 February 2023
|
28 February 2028
|
| View |
|
DRP-13529
|
Clotrimazole
|
Fungorig 1%
|
10mg/g (1% w/w)
|
Cream
|
-
|
Next Wave (India)
|
India
|
DRP-13529
|
07 March 2023
|
07 March 2028
|
| View |
|
DRP-13514
|
Omeprazole (as Sodium)
|
Eproz
|
40 mg
|
Lyophilized Powder For Injection (IV)
|
-
|
Nitin Lifesciences Ltd. (Unit III)
|
India
|
DRP-13514
|
02 March 2023
|
02 March 2028
|
| View |
|
DRHR-2213
|
Chlorhexidine Diguconate
|
Hyclens Skin Cleanser
|
40 mg/mL (4 % w/v)
|
Solution
|
-
|
Maridan Industries Inc.
|
Philippines
|
Initial (Correction)
|
28 September 2023
|
06 March 2028
|
| View |
|
DR-XY48636
|
Spherical Carbon Adsorbent
|
Kremezin
|
500 mg
|
Tablet
|
-
|
Sato Yakuhin Kogyo Co., Ltd.
|
Japan
|
DR-XY48636
|
06 March 2023
|
06 March 2028
|
| View |
|
DR-XY34712
|
Perindopril Erbumine
|
Perigard-4
|
4mg
|
Tablet
|
Angiotensin Converting Enzyme (ACE) Inhibitor
|
Glenmark Pharmaceuticals Ltd.
|
India
|
Automatic Renewal
|
07 March 2023
|
10 July 2028
|
| View |
|
DR-XY44292
|
Rifampicin + Isoniazid
|
Duopedia Kit
|
200mg/200mg / 5mL
|
Suspension/Syrup
|
Antituberculosis
|
San Marino Laboratories Corporation
|
Philippines
|
Automatic Renewal
|
15 March 2023
|
24 March 2028
|
| View |
|
DRP-4378-04
|
Loperamide Hydrochloride
|
Ramide
|
2 mg
|
Capsule
|
Antimotility
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Automatic Renewal
|
20 March 2023
|
18 March 2028
|
| View |
|
DRP-6679-01
|
Oxacillin (as sodium)
|
Oxas
|
500 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin)
|
Reyoung Pharmaceutical Co. Ltd
|
China
|
Renewal
|
13 March 2023
|
02 May 2028
|
| View |
|
DRP-771-03
|
Vitamin Bcomplex + Iron + Folic Acid
|
Nicoplex Ob
|
200 mg/10 mg/5 mg/5 mg/20 mcg/400 mcg
|
Capsule
|
Antianemic Preparations
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
15 March 2023
|
08 November 2027
|
| View |
|
HMR-153
|
Vitex Negundo (Lagundi Leaf)
|
None
|
600 mg/5mL
|
Syrup
|
Herbal Medicine (Anti-cough/Antiasthma)
|
Northfield Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
10 March 2023
|
02 March 2028
|
| View |
|
HRP-421
|
Povidone Iodine
|
MAXI-AID
|
75mg/mL (7.5% w/v)
|
Topical Solution
|
Antiseptic
|
Primecare Lifesciences Laboratories Corp.
|
Philippines
|
Automatic Renewal
|
13 March 2023
|
17 March 2028
|
| View |
DR-XY47942_PI_01.pdf
|
DR-XY47942
|
Daclatasvir (as dihydrochloride)
|
Virdac 30
|
30 mg
|
Film-Coated Tablet
|
Antiviral
|
Hetero Labs Limited (Unit V)
|
India
|
Monitored Release
|
18 April 2022
|
18 April 2027
|
| View |
DR-XY47943_PI_01.pdf
|
DR-XY47943
|
Daclatasvir (as dihydrochloride)
|
Virdac 60
|
60 mg
|
Film-Coated Tablet
|
Antiviral
|
Hetero Labs Limited (Unit V)
|
India
|
Monitored Release
|
18 April 2022
|
18 April 2027
|
| View |
|
DRP-12893
|
Ezetimibe
|
Exelzio
|
10 mg
|
Tablet
|
-
|
KRKA, d.d., Novo Mesto
|
Slovenia
|
Initial
|
27 October 2022
|
27 October 2027
|
| View |
|
DRP-10091-06
|
Norepinephrine (as bitartrate)
|
Dynophrine
|
1 mg/mL (4mg/4mL)
|
Solution for I.V. Injection
|
-
|
Aju Pharm Co., Ltd
|
Korea
|
CLIDP Conversion
|
03 October 2022
|
21 October 2025
|
| View |
|
DRP-10243-01
|
Fusidic Acid
|
Fuziem
|
20 mg/g (2% w/w)
|
Cream
|
Antibiotics for Topical Use (Antibacterial)
|
Encube Ethicals Pvt. Ltd.
|
India
|
Renewal
|
28 March 2023
|
16 August 2028
|
| View |
|
DRP-12319
|
Carboplatin
|
Carbonish-450
|
10 mg/mL (450 mg/45 mL)
|
Solution for IV Infusion
|
Antineoplastic
|
Admac Lifesciences
|
India
|
Renewal
|
22 March 2023
|
29 July 2028
|