| View |
|
DRP-4184-12
|
Paracetamol
|
Paracure
|
500 mg
|
Tablet
|
Analgesic/Antipyretic
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Renewal
|
11 February 2023
|
08 January 2028
|
| View |
|
DRP-4474-16
|
Ceftriaxone (as sodium)
|
Ceftrone
|
1 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
Brawn Laboratories Ltd.
|
India
|
CLIDP Conversion
|
14 November 2022
|
13 June 2028
|
| View |
|
DRP-11944-03
|
Clotrimazole
|
Fungivate
|
10 mg/g (1% w/w)
|
Topical Cream
|
Antifungal
|
KLM Laboratories Pvt. Ltd.
|
India
|
CLIDP Conversion
|
14 November 2022
|
23 May 2027
|
| View |
|
DRP-12955
|
Fusidic Acid
|
Fusidek
|
20mg/g (2% w/w)
|
Topical Cream
|
Antibacterial
|
KLM Laboratories Pvt. Ltd.
|
India
|
Initial (OTC)
|
09 November 2022
|
09 November 2027
|
| View |
|
DRP-12956
|
Terbinafine Hydrochloride
|
Terbifred
|
10mg/g (1% w/w)
|
Topical Cream
|
Antifungal
|
Fredun Pharmaceuticals Limited
|
India
|
Initial (OTC)
|
09 November 2022
|
09 November 2027
|
| View |
BR-1428_PI_01.pdf
|
BR-1428
|
Nonacog Alfa
|
BeneFIX
|
500IU
|
Lyophilized Powder for Solution for Injection (IV)
|
Blood Coagulation Factors (Coagulation Factor IX)
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release (MR)
|
08 November 2022
|
08 November 2027
|
| View |
BR-1430_PI_01.pdf
|
BR-1430
|
Nonacog Alfa
|
BeneFIX
|
2000IU
|
Lyophilized Powder for Solution for Injection (IV)
|
-
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release
|
08 November 2022
|
08 November 2027
|
| View |
BR-1429_PI_01.pdf
|
BR-1429
|
Nonacog alfa
|
BeneFIX
|
1000IU
|
Lyophilized Powder for Solution for Injection (IV)
|
Blood Coagulation Factors (Coagulation Factor IX)
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release (MR)
|
08 November 2022
|
08 November 2027
|
| View |
|
DR-XY48454
|
Ascorbic Acid
|
Effi-C
|
1 g
|
Effervescent Tablet
|
-
|
Scitech Specialties Pvt. Ltd.
|
India
|
Initial (OTC)
|
10 November 2022
|
10 November 2027
|
| View |
|
DRP-12936
|
Ascorbic Acid + Cholecalciferol (vitamin D3) + Zinc
|
CGEN Plus D1000
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/ 1000 IU/ 10 mg (equivalent to 70 mg Zinc Gluconate)
|
Capsule
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)
|
10 November 2022
|
10 November 2027
|
| View |
|
DRP-12960
|
Phytomenadione
|
Menadon
|
10 mg/mL
|
Solution for Injection (I.M./I.V./S.C.)
|
Antihemorrhagic (Vitamin K)
|
Suicheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
09 November 2022
|
09 November 2027
|
| View |
|
DRP-12947
|
Cetirizine Hydrochloride
|
Ricam
|
10mg
|
Tablet
|
Antihistamine
|
Hovid Bhd.
|
Malaysia
|
Initial (OTC)
|
08 November 2022
|
08 November 2027
|
| View |
|
DRP-12932
|
Omeprazole
|
Omeprasaph
|
20 mg
|
Delayed-Release Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
04 November 2022
|
04 November 2027
|
| View |
|
DRP-12935
|
Acetylcysteine
|
Cetysl
|
200 mg
|
Powder For Oral Solution
|
Mucolytic
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
04 November 2022
|
04 November 2027
|
| View |
|
DRP-12934
|
Lidocaine Hydrochloride
|
Lidophil
|
20 mg/mL (2% w/v)
|
Solution For Injection (IV)
|
Local Anaesthetic
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
24 January 2023
|
04 November 2027
|
| View |
|
DRP-12933
|
Clindamycin (as phosphate)
|
Clindaphil
|
150 mg/mL
|
Solution For Injection (I.M./I.V.)
|
Antibacterial (Lincosamide)
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
04 November 2022
|
04 November 2027
|
| View |
|
DRP-12959
|
Tacrolimus
|
None
|
500 mcg
|
Capsule
|
Immunosuppressant (Calcineurin Inhibitor)
|
Medicamen Organics Limited (Unit II)
|
India
|
Initial
|
09 November 2022
|
09 November 2027
|
| View |
|
DR-XY48458
|
Methotrexate
|
Metotrek
|
25 mg/mL (500 mg/20 mL)
|
Solution for Injection (IM/IV)
|
Antineoplastic Agent (Folic Acid Analogue)
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
08 November 2022
|
08 November 2027
|
| View |
|
DRP-12931
|
Aminophylline
|
Saphylline
|
25mg/mL
|
Solution For Injection (IV)
|
Bronchodilator
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
04 November 2022
|
04 November 2027
|
| View |
|
DRP-12953
|
Biotin (Vitamin B7)
|
Saphbiotin
|
5 mg
|
Film-Coated Tablet
|
Vitamin
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (OTC)
|
08 November 2022
|
08 November 2027
|