View |
|
DRP-12791
|
Amlodipine (As Besylate) + Hydrochlorothiazide
|
Lodipex HCTZ
|
10mg/12.5mg
|
Tablet
|
Calcium channel blocker and diuretic
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
28 October 2022
|
28 October 2027
|
View |
|
FDA-0587624
|
Ezetimibe
|
Exelzio
|
10 mg
|
Tablet
|
-
|
KRKA, d.d., Novo Mesto
|
|
Initial
|
27 October 2022
|
27 October 2027
|
View |
|
DR-XY46770
|
Cefuroxime
|
Ducef
|
750mg
|
Dry Powder for Injection (IM/IV)
|
Anti-infectives (Second-generation cephalosporins)
|
Theon Pharmaceuticals Limited
|
India
|
Initial (Correction)(Reconstruction)
|
03 November 2022
|
27 November 2024
|
View |
|
DR-XY46771
|
Cefuroxime Sodium
|
Ducef
|
1.5g
|
Dry Powder for Injection (IM/IV)
|
Anti-infectives (Second-generation cephalosporins)
|
Theon Pharmaceuticals Limited
|
India
|
Initial (Correction)(Reconstruction)
|
03 November 2022
|
27 November 2024
|
View |
|
DRP-8569
|
Ascorbic Acid + Zinc
|
CIXTOR-Z
|
20.759mg (Equi. To 23.35mg Sodium Ascorbate)
24.25mg (Equi. To 28.6mg Zinc Ascorbate)
4.5mg
|
Syrup (Oral Drops)
|
Vitamin and Mineral
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
30 August 2022
|
11 September 2027
|
View |
|
DRP-11151-01
|
Cefuroxime (as axetil)
|
Cefromaxil
|
500 mg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc
|
Philippines
|
CLIDP Conversion
|
01 June 2022
|
08 February 2027
|
View |
|
DRP-13001
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
Co-Altria Ped
|
5mg/5mg
|
Chewable Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
PCPR Conversion
|
17 November 2022
|
01 April 2027
|
View |
|
DRP-12985
|
Losartan Potassium + Amlodipine (as besilate)
|
Amlife
|
50 mg/5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Antagonist/Calcium Channel Blocker
|
Ajanta Pharma Limited
|
India
|
Renewal
|
30 June 2023
|
24 October 2028
|
View |
|
DRP-12986
|
Losartan Potassium + Amlodipine (as besilate)
|
Amlife
|
100 mg/5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Antagonist/Calcium Channel Blocker
|
Ajanta Pharma Limited
|
India
|
Renewal
|
19 December 2023
|
03 March 2029
|
View |
|
DRP-12987
|
Losartan Potassium + Amlodipine (as besilate)
|
Amlife
|
100 mg/10 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Antagonist/Calcium Channel Blocker
|
Ajanta Pharma Limited
|
India
|
Renewal
|
19 November 2023
|
03 March 2029
|
View |
|
DRP-1252-06
|
PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE
|
SINUDEX
|
325 mg/25 mg/10 mg
|
Capsule
|
ANALGESIC / ANTIPYRETIC / NASAL DECONGESTANT / ANTITUSIVE
|
J.M. Tolmann Laboratories Inc
|
Philippines
|
Renewal
|
04 August 2023
|
20 August 2028
|
View |
|
DRP-5052-23
|
Cefixime (as trihydrate)
|
Nibexime
|
100 mg/5 mL
|
Granules for Suspension
|
-
|
J.M. Tolmann Laboratories Inc
|
Philippines
|
CLIDP Conversion
|
18 November 2022
|
18 August 2027
|
View |
|
DRP-6382-02
|
Sitagliptin (as phosphate monohydrate)
|
Sitajack
|
100 mg
|
Film-Coated Tablet
|
-
|
Bafna Pharmaceutical Limited
|
India
|
CLIDP Conversion
|
18 November 2022
|
09 October 2025
|
View |
|
DRP-6498-07
|
Pantoprazole (as sodium)
|
Pantocent
|
40 mg
|
Powder for Solution for Injection (IV)
|
-
|
Hanlim Pharmaceutical Co., Ltd
|
Korea
|
CLIDP Conversion
|
18 November 2022
|
20 April 2026
|
View |
|
DRP-6559-03
|
Dibencozide
|
Cozin
|
1 mg
|
Capsule
|
Vitamins
|
LifeSquare Laboratories, Inc
|
Philippines
|
Renewal
|
05 February 2024
|
03 March 2029
|
View |
|
DRP-9391-05
|
Telmisartan
|
Telcor 80
|
80 mg
|
Film-Coated Tablet
|
-
|
Mars Therapeutics Private Limited
|
India
|
CLIDP Conversion
|
18 November 2022
|
02 March 2026
|
View |
|
DRP-9975-08
|
Cefuroxime (as axetil)
|
Jaxime
|
500 mg
|
Film-Coated Tablet
|
-
|
Theon Pharmaceuticals Limited
|
India
|
CLIDP Conversion
|
18 November 2022
|
01 July 2026
|
View |
|
DRP-11078-01
|
Racecadotril
|
Racetril
|
30 mg
|
Granules for Oral Suspension
|
-
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
CLIDP Conversion
|
18 November 2022
|
26 January 2027
|
View |
|
DRP-11270-03
|
Miconazole Nitrate
|
Micolan
|
20 mg/g (2% w/w)
|
Topical Cream
|
-
|
KLM Laboratories Pvt. Ltd
|
India
|
CLIDP Conversion
|
18 November 2022
|
22 February 2027
|
View |
|
DRP-12392-06
|
Cefalexin (as monohydrate)
|
Ceplegen
|
100 mg/mL
|
Powder for Suspension for Oral Drops
|
Antibacterial (First Generation Cephalosporins)
|
Azarias Pharmaceutical Laboratories Inc
|
Philippines
|
CLIDP Conversion
|
18 November 2022
|
21 July 2027
|