| View |
|
DR-XY47856
|
Daclastavir (As dihydrochloride)
|
Dacihep 30
|
30 mg
|
Film Coated Tablet
|
Antiviral for treatment of Hepatits C Virus (HCV) Infection
|
Cadila Healthcare Limited
|
India
|
Monitored Release
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47857
|
Daclastavir Dihydrochloride
|
Dacihep 30
|
30 mg
|
Film Coated Tablet
|
Antiviral for treatment of Hepatits C Virus (HCV) Infection
|
Cadila Healthcare Limited
|
India
|
Monitored Release
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47858
|
Daclastavir (As dihydrochloride)
|
Dacihep 60
|
60 mg
|
Film Coated Tablet
|
Antiviral for treatment of Hepatits C Virus (HCV) Infection
|
Cadila Healthcare Limited
|
India
|
Monitored Release
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11586
|
Ibandronic Acid (as sodium monohydrate)
|
Ibanox
|
50 mg
|
Film-Coated Tablet
|
-
|
Pharmathen SA
|
Greece
|
-
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-11585
|
Ibandronic Acid (as sodium monohydrate)
|
Ibanox
|
150 mg
|
Film-Coated Tablet
|
Bisphosphonate
|
Pharmathen SA
|
Greece
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-11513
|
Moxifloxacin
|
Moxiflostad
|
400mg (equivalent to 436.80mg Moxifloxacin hydrochloride)
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
Hemofarm A.D.
|
Serbia
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
BR-1391
|
Heparin Sodium
|
Avirin
|
1,000 IU/mL
|
Solution for Injection (IV/SC)
|
Antithrombotic Agents
|
2 World Laboratories
|
India
|
Renewal
|
30 March 2022
|
11 August 2026
|
| View |
|
DRP-11511
|
Moxifloxacin (as hydrochloride) + Dexamethasone
phosphate (as sodium)
|
Lumemox-D
|
5 mg/1 mg per mL (0.5% w/v/0.1% w/v)
|
Sterile Ophthalmic Solution (Eye Drops)
|
Antibacterial (Fluoroquinolone)/
Corticosteroid (Glucocorticoid)
|
Axa Parenterals Limited
|
India
|
Initial (Reconstruction)
|
12 August 2024
|
30 March 2027
|
| View |
|
DR-XY47837
|
Methylcobalamin (Vitamin B12)
|
Neurosum
|
500 mcg
|
Tablet
|
Vitamin
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47833
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Co-Altria
|
10mg/5mg
|
Tablet
|
Leukotriene Receptor Antagonist/Antihistamine
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release status) [Reconstruction]
|
13 December 2022
|
18 March 2027
|
| View |
|
DR-XY47829
|
Erlotinib Hydrochloride
|
Erluntas
|
150 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Protein kinase inhibitor)
|
Remedica Ltd.
|
Cyprus
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47872
|
Fluconazole
|
Flukal
|
200mg in 100mL (2mg/mL)
|
Solution for Intravenous Infusion
|
Antimycotics for systematic use (triazole and Tetrazole Derivative
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47873
|
Fluconazole
|
Axa-Zole F
|
2mg/mL (200 mg/100 mL)
|
Solution for Intravenous Infusion
|
Antimycotics for systematic use (triazole and Tetrazole Derivative
|
Axa Parenterals Limited
|
India
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47859
|
Clotrimazole
|
Candigo
|
100 mg/g (10% w/w)
|
Vaginal Cream
|
Anti-Infective and Antiseptic (Imidazole derivative)
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47840
|
Pioglitazone (as hydrochloride) + Metformin (as
hydrochloride)
|
Lodiglit
|
15 mg / 850 mg
|
Film Coated Tablet
|
Oral Hypoglycemic
|
Standard Chem. & Pharm. Co., Ltd. (Plant II)
|
Taiwan
|
Monitored Release
|
29 March 2022
|
29 March 2027
|
| View |
|
DRP-8361-01
|
Paracetamol
|
Mcgesic 125
|
125 mg
|
Rectal Suppository
|
Analgesic / Antipyretic
|
Bliss GVS Pharma Ltd. (Unit II)
|
India
|
CLIDP
|
28 March 2022
|
23 September 2026
|
| View |
|
HMRP-40
|
Plantago ovata Forssk. (Ispaghula husk)
|
Mucilin SF
|
3.5g/5 g
|
Powder for Oral Suspension
|
-
|
Berlin Pharmaceutical Industry Co., Ltd.
|
Thailand
|
-
|
17 February 2022
|
22 February 2026
|
| View |
|
HRP-336
|
Carbocisteine
|
Carbosaph-C500
|
500mg
|
Capsule
|
Mucolytic
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Automatic Renewal
|
12 October 2022
|
23 June 2027
|
| View |
|
HRP-366
|
Hydroquinone + Tretinoin
|
None
|
20mg/250mcg per g (2%/0.025% w/w)
|
Cream
|
-
|
Stalder Laboratories, Inc.
|
Philippines
|
-
|
21 March 2022
|
27 May 2027
|
| View |
|
HRP-408
|
Zinc Oxide
|
Caloderm
|
400mg/g
|
Ointment
|
Topical Protectant
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial (Variation: PCPR Conversion) [Revalidation]
|
25 August 2022
|
16 December 2025
|