| View |
|
DRP-13888
|
Iron (as Iron Sucrose)
|
Anemles
|
20 mg/mL (100 mg/5 mL)
|
Solution for Injection (IV)
|
-
|
Makcur Laboratories Limited
|
India
|
Initial
|
11 May 2023
|
11 May 2028
|
| View |
|
DRP-13901
|
Salbutamol (as sulafte) + Ipratropium Bromide
|
Amsulduo
|
2.5 mg/500 mcg per 2.5 mL
|
Solution For Inhalation
|
-
|
Ahlcon Parenterals (India) Limited
|
India
|
Initial (Correction)
|
02 October 2023
|
15 May 2028
|
| View |
|
DRP-13885
|
Ascorbic Acid + Zinc+ d-alpha Tocopheryl succinate (Vitamin E)
|
Saphzeemin
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate) / 20 mg (equivalent to 54.89 mg Zinc Sulfate Monohydrate) / 50 IU
|
Film-Coated Tablet
|
Vitamins / Mineral
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (Correction)
|
30 January 2024
|
16 May 2028
|
| View |
|
DPP-13902
|
Citicoline (as sodium)
|
Citisaph-500
|
500 mg
|
FIlm- Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
15 May 2023
|
15 May 2028
|
| View |
|
DRP-13903
|
Citicoline (as sodium)
|
Citisaph-1000
|
100mg/ml (500mg/5ml)
|
Syrup
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
15 May 2023
|
15 May 2028
|
| View |
|
DRP-13904
|
Citicoline (as sodium)
|
Citisaph-500
|
100mg/ml (500mg/5mL)
|
Syrup
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
15 May 2023
|
15 May 2028
|
| View |
|
DRP-13896
|
Irbesartan
|
Arvezar
|
150 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
12 May 2023
|
12 May 2028
|
| View |
|
DRP-13905
|
Citicoline
|
Citisaph
|
100 mg/mL
|
Syrup (Oral Drops)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
15 May 2023
|
15 May 2028
|
| View |
|
DRP-13895
|
Sodium Bicarbonate
|
Bicarbisaph
|
650 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
12 May 2023
|
12 May 2028
|
| View |
|
DRP-13920
|
Rasagiline (as tartrate)
|
Rasagen
|
1 mg
|
Tablet
|
-
|
Remedica Ltd. (Building 1 - General Products)
|
Cyprus
|
Initial
|
17 May 2023
|
17 May 2028
|
| View |
|
DR-XY48706
|
Vancomycin Hydrochloride
|
Vancomax
|
500 mg
|
Powder For Injection I.V. Infusion
|
-
|
Reyoung Pharmaceutical Co. Ltd.
|
China
|
Initial (Reapplication)
|
15 May 2023
|
15 May 2028
|
| View |
|
DR-XY48707
|
Vancomycin Hydrochloride
|
Vancomax
|
1 g
|
Powder for I.V. Infusion
|
-
|
Reyoung Pharmaceutical Co. Ltd.
|
China
|
Initial (Reapplication)
|
15 May 2023
|
15 May 2028
|
| View |
|
DRP 4614-02
|
Azithromycin (as dihydrate)
|
None
|
500 mg
|
Film-Coated Tablet
|
-
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial (Variation)
|
15 May 2023
|
06 May 2027
|
| View |
|
DRP-8468
|
Cefixime (As Trihydrate)
|
Vamocef
|
100 mg per 5 mL
|
Granules For Suspension
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
29 May 2023
|
04 September 2028
|
| View |
|
DRP-10193
|
Gemcitabine (as Hydrochloride)
|
Gempower
|
200 mg
|
Lyophilized Powder For Injection (I.V)
|
Antineoplastic
|
Khandelwal Laboratories Pvt. Ltd.
|
India
|
Automatic Renewal (Variation: PCPR Conversion)
|
29 May 2023
|
27 September 2028
|
| View |
|
DR-XY37789
|
Triamcinolone Acetonide + Neomycin (As Sulfate) + Gramicidin + Nystatin
|
Quadcomb
|
1mg/2.5mg/250mcg/100,000units per mL
|
Otic Suspension
|
Cortecosteroid/Antibacterial/Antifungal
|
Ashford Pharmaceutical Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
29 May 2023
|
25 June 2028
|
| View |
|
DRP-176-10
|
Multivitamins + Iron
|
None
|
Formulation: Each capsule contains:
Thiamine hydrochloride (Vitamin B1)-10mg Riboflavin (Vitamin B2)-10mg Nicotinamide (Vitamin. B3)-25mg Calcium Pantothenate (Vitamin B5)-10mg Pyridoxine hydrochloride (Vitamin B6)-5mg
Ascorbic Acid (Vitamin C)-100mg Cyanocobalamin (Vitamin B12)-25mcg Folic Acid-950mcg Ferrous Fumarate
(eq. to 105 elemental iron)-325 mg
|
Capsule
|
Vitamins and Minerals
|
Scheele Laboratories Phil. Inc.
|
Philippines
|
Automatic Renewal
|
29 May 2023
|
14 April 2028
|
| View |
|
DRP-2299-01
|
Doxorubicin Hydrochloride
|
None
|
10 mg
|
Lyophilized Powder for Injection (IV)
|
Antineoplastic (Anthracycline and related substances)
|
Celon Laboratories Private Limited
|
India
|
Renewal
|
29 May 2023
|
02 July 2028
|
| View |
|
DRP-4924-05
|
Cisplatin
|
Cisplaxil
|
1 mg/mL (50 mg/50mL)
|
Solution For Injection (IV)
|
Antineoplastic (Cell Cycle-Nonspecific Agent)
|
Getwell Pharmaceuticals
|
India
|
Automatic Renewal
|
19 May 2023
|
14 November 2028
|
| View |
|
DRP-4753
|
Losartan Potassium + Hydrochlorothiazide
|
Thiaxtan
|
100 mg/25 mg
|
Tablet
|
Angiotensin II Antagonist/ Diuretic
|
Square Pharmaceuticals, Inc.
|
Philippines
|
Renewal
|
04 August 2024
|
30 September 2029
|