View |
DRP-13159-01_PI_01.pdf
|
DRP-13159-01
|
Amiodarone Hydrochloride
|
Adaron
|
50 mg/mL (150 mg/3 mL)
|
Sterile Concentrate Solution for IV Infusion
|
Antiarrhythmic Agent
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
CLIDP Conversion
|
30 March 2023
|
12 December 2027
|
View |
DRP-7387-07_PI_01.pdf
|
DRP-7387-07
|
Vancomycin (as Hydrochloride)
|
Vancophar
|
1 g
|
Powder for Injection (I.V. Infusion)
|
Antibacterial (Glycopeptide)
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
CLIDP Conversion
|
23 August 2023
|
04 October 2027
|
View |
DRP-11397-01_PI_01.pdf
|
DRP-11397-01
|
Vancomycin
|
Vancosan
|
1 g
|
Powder for Injection (I.V.)
|
Antibacterial (Glycopeptide)
|
Reyoung Pharmaceutical Co. Ltd.
|
China
|
CLIDP Conversion
|
01 August 2023
|
08 March 2027
|
View |
DRP-11847-04_PI_01.pdf
|
DRP-11847-04
|
Sitagliptin (as phosphate monohydrate) + Metformin Hydrochloride
|
Xiglip M
|
50 mg/ 1 g
|
Film-Coated Tablet
|
Combination of Oral Blood Glucose Lowering Drugs
|
Fredun Pharmaceuticals Limited
|
India
|
CLIDP Conversion
|
15 July 2023
|
10 May 2027
|
View |
DRP-12289-03_PI_01.pdf
|
DRP-12289-03
|
Sitagliptin (as phosphate)
|
Xiglip
|
100 mg
|
Film-Coated Tablet
|
Dipeptidyl peptidase 4 (DPP-4) inhibitor
|
Fredun Pharmaceuticals Limited
|
India
|
CLIDP Conversion
|
30 March 2023
|
08 July 2027
|
View |
DR-XY38725_PI_01.pdf
|
DR-XY38725
|
Cefaclor (as monohydrate)
|
Syfaclor
|
250mg/ 5 mL
|
Powder for Suspension
|
Antibacterial (Cephalosporin)
|
Sydenham Laboratories, Inc.
|
Philippines
|
Renewal (Variation)
|
22 April 2021
|
05 November 2025
|
View |
DR-XY47929_PI_01.pdf
|
DR-XY47929
|
Linagliptin + Metformin Hydrochloride
|
Trajenta Duo
|
2.5 mg/1 g
|
Film-Coated Tablet
|
Drugs Used In Diabetes (Combinations Of Oral Blood Glucose Lowering Drugs)
|
|
|
Initial (Variation)
|
10 August 2022
|
12 April 2027
|
View |
|
DR-XY47205
|
Metronidazole
|
Zolpas
|
500mg/ 100mL
|
Solution for I.V. Infusion
|
Antiprotozoal
|
Eurolife Healthcare Pvt. Ltd.
|
India
|
Initial
|
19 March 2021
|
19 March 2026
|
View |
|
DR-XY47206
|
Levofloxacin
|
Miraden
|
500mg/ 100mL
|
Solution for Intravenous Infusion
|
Antibacterial (Fluoroquinolones)
|
Eurolife Healthcare Pvt. Ltd.
|
India
|
Initial
|
30 March 2021
|
30 March 2026
|
View |
|
DR-XY48401
|
Indacaterol (as acetate) + Mometasone furoate
|
Atectura Breezhaler
|
150 mcg/ 160 mcg (equivalent to 125 mcg/ 127.5 mcg
delivered dose)
|
Powder for Inhalation in Hard Capsule
|
Adrenergic-Corticosteroid Combination
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
View |
|
BR-1058
|
Somatropin (rbe)
|
Scitropin A
|
10 mg/1.5 mL
|
Solution For Injection (SC)
|
Growth Hormone
|
Sandoz GmbH
|
Austria
|
Renewal
|
08 September 2024
|
03 August 2029
|
View |
|
DRP-5427-03
|
Cetirizine Hydrochloride
|
Cetriset
|
10 mg
|
Tablet
|
Antihistamine
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Renewal
|
11 August 2024
|
08 August 2029
|
View |
|
DRP-8376-02
|
Cefepime (as hydrochloride)
|
ZEFAROX
|
1 g
|
Powder For Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
CSPC Zhongnuo Pharmaceutical (Shijianzhuang) Co. Ltd.
|
China
|
Renewal
|
10 October 2024
|
18 September 2029
|
View |
|
DRP-2114-13
|
Vitamin B-Complex (see reverse)
|
Curanerve
|
Formulation: Each capsule contains: Thiamine Mononitrate (Vitamin B1)-300mg Pyridoxine Hydrochloride (Vitamin B6)-100mg Cyanocobalamin (Vitamin B12)-100mcg
|
Capsule
|
Vitamins
|
Lloyd Laboratories, Inc.
|
Philippines
|
Renewal
|
09 October 2024
|
01 October 2029
|
View |
|
DR-XY43911
|
Cinacalcet (as hydrochloride)
|
Calcipar
|
30 mg
|
Film-Coated Tablet
|
Anti-parathyroid Agent
|
Ind-Swift Limited
|
India
|
Monitored Release
|
25 March 2022
|
24 November 2024
|
View |
|
HRP-129-04
|
Ascorbic Acid
|
Boost-Cee
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate)
|
Capsule
|
Vitamin
|
Growrich Manufacturing Inc.
|
Philippines
|
Initial
|
06 July 2021
|
25 November 2024
|
View |
|
HRP-129-05
|
Ascorbic Acid
|
Lin-Cee
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate)
|
Capsule
|
Vitamin
|
Growrich Manufacturing Inc.
|
Philippines
|
Initial
|
06 July 2021
|
25 November 2024
|
View |
|
HRP-129-06
|
Ascorbic Acid
|
Great-Cee
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate)
|
Capsule
|
Vitamin
|
Growrich Manufacturing Inc.
|
Philippines
|
Initial
|
06 July 2021
|
25 November 2024
|
View |
|
BR-233
|
Hepatitis B (rDNA) Vaccine
|
Engerix-B
|
20mcg/mL
|
Suspension for IM Injection (Thiomersal-free/Preservative-free)
|
Vaccine
|
GlaxoSmithKline Biologicals SA
|
Belgium
|
Renewal
|
04 June 2021
|
04 December 2024
|
View |
|
BR-254
|
Hepatitis B (rDNA) Vaccine
|
Engerix-B
|
10mcg/0.5mL
|
Suspension for IM Injection (Thiomersal-free/Preservative-free)
|
Vaccine
|
GlaxoSmithKline Biologicals SA
|
Belgium
|
Renewal
|
04 June 2021
|
04 December 2024
|