| View |
|
DRP-12952
|
Cetirizine (as dihydrochloride)
|
Allecur D
|
10 mg
|
Tablet
|
Antihistamine
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
09 November 2022
|
09 November 2027
|
| View |
|
DRP-12958
|
Sitagliptin (As Phosphate Monohydrate)
|
Diasutin-100
|
100 mg
|
Film Coated Tablet
|
-
|
Theon Pharmaceuticals Limited
|
India
|
Initial
|
09 November 2022
|
09 November 2027
|
| View |
|
DRP-12942
|
Telmisartan + Amlodipine (As Besylate)
|
Telmisaph-A50
|
40mg/10mg
|
Tablet
|
Angiotensin II Receptor Blocker/ Calcium Channel
Blocker
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
04 November 2022
|
04 November 2027
|
| View |
BR-1427_PI_01.pdf
|
BR-1427
|
Nonacog Alfa
|
BeneFIX
|
250IU
|
Lyophilized Powder for Solution for Injection (IV)
|
-
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release (MR)
|
08 November 2022
|
08 November 2027
|
| View |
|
DRP-12950
|
5% Dextrose in 0.9% Sodium Chloride
|
Axadex DNS
|
5 g/900 mg per 100 mL
|
Intravenous Infusion
|
Electrolyte Replenisher
|
AXA Parenterals Limited
|
India
|
Initial
|
08 November 2022
|
08 November 2027
|
| View |
|
DRP-12951
|
Sitagliptin (as phosphate)
|
Instadip 100
|
100 mg
|
Film-Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial (Reconstruction)
|
22 May 2024
|
08 November 2027
|
| View |
|
DRP-12632
|
Multivitamins + Minerals
|
Ingesta For Adults
|
Formulation Each tablet contains:
Calcium (as Calcium Carbonate and Calcium Hydrogen Phosphate Anhydrous), USP............200mg . Vitamin C (Ascorbic Acid). USP...........90mg Magnesium (as Oxide), USP ...............50mg Phosphorus (as Calcium Hydrogen Phosphate Anhydrous), USP........50mg Vitamin B3 (Niacinamide). USP............15mg Vitamin B5 (as Calcium Pantothenate), USP.............10mg . Vitamin B6 (Pyridoxine Hydrochloride). USP................8mg Zinc (as Oxide), USP ......7.50mg Iron (as Ferrous Fumarate), USP..............4mg Manganese (as Sulfate Monohydrate)...............3.50 mg
Vitamin B2 (as Riboflavine-5- Phosphate Sodium), USP...............3.20mg Vitamin B1 (as Thiamine Mononitrate), USP ...........2.18mg Copper (as Sulfate Pentahydrate).............500mcg Vitamin B9 ( Folic Acid), USP...........300mcg Iodine (as Potassium Iodide). USP..............150mcg Selenium (as Sodium Selenite). BP..................55mcg Vitamin B12 (Cyanocobalamine), USP............25mcg Vita nin A (as Acetate). USP ............... 2840IU Vitamin A (as Beta-Carotene 10%)..............1160IU Vitamin D3 (Cholecalciferol), USP...............600IU Vitamin E (d-Alpha-Tocopheryl Acetate) ...........75IU
|
Film Coated Tablet
|
Vitamins And Minerals
|
Phil. United Pharma Corp.
|
Philippines
|
Initial (OTC)
|
08 November 2022
|
08 November 2027
|
| View |
|
DRP-12913
|
Furosemide
|
Rosero
|
10 mg/mL (20 mg/2 mL)
|
Solution For Injection (IM/IV)
|
Diuretics
|
Steril-Gene Life Sciences (P) Ltd.
|
india
|
Initial
|
04 November 2022
|
04 November 2027
|
| View |
DR-XY48460_PI_01.pdf
|
DR-XY48460
|
Emtricitabine + Tenofovir alafenamide (as hemifumarate)
|
Tafnext -Em
|
200 mg/25 mg
|
Tablet
|
Direct Acting Antiviral
|
Annora Pharma Private Limited
|
India
|
Monitored Release (MR)
|
09 November 2022
|
09 November 2027
|
| View |
|
DR-XY48451
|
Metformin Hydrochloride
|
Meforin
|
500mg
|
Tablet
|
-
|
Celogen Generics Private Ltd.
|
India
|
Initial
|
07 November 2022
|
07 November 2027
|
| View |
|
DRP-12916
|
Ascorbic Acid
|
Acce-C
|
100mg/mL
|
Solution for Injection (IM/IV)
|
Vitamin
|
Joint Stock Company "Lekhim-Kharkiv"
|
Ukraine
|
Initial
|
07 November 2022
|
07 November 2027
|
| View |
|
BR-1410
|
Sulodexide
|
Angioflux
|
250 LSU
|
Softgel Capsule
|
-
|
Catalent Italy S.P.A.
|
Italy
|
Automatic Renewal (Reconstruction)
|
23 August 2022
|
28 December 2025
|
| View |
|
DRP-13093
|
Phenylephrine Hydrochloride (Melon Flavor)
|
Nasadrin
|
12.5 mg/ 5 mL
|
Syrup
|
Decongestant
|
Lloyd Laboratories, Inc.
|
Philippines
|
Renewal
|
23 May 2024
|
10 September 2029
|
| View |
|
DRP-13094
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Co-Altria
|
10mg/5mg
|
Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
PCPR Conversion
|
29 November 2022
|
26 July 2027
|
| View |
DRP-13024_PI_01.pdf
|
DRP-13024
|
Rosuvastatin (as calcium)
|
Lowas 10
|
10 mg
|
Film-Coated Tablet
|
HMG CoA Reductase Inhibitor
|
XL Laboratories Pvt. Ltd.
|
India
|
Renewal
|
25 July 2024
|
23 March 2030
|
| View |
|
DRP-13026
|
Tamsulosin hydrochloride
|
Prostanil MR
|
400 mcg
|
Prolonged-Release Capsule
|
-
|
Aristopharma Ltd.
|
Bangladesh
|
PCPR Conversion
|
22 November 2022
|
23 August 2027
|
| View |
|
DRP-13023
|
Cetirizine Dihydrochloride
|
Alerid
|
10 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratoties, Inc
|
Philippines
|
PCPR Conversion
|
21 November 2022
|
28 December 2026
|
| View |
|
DRP-10088-04
|
Nicardipine Hydrochloride
|
Nicabloc
|
1mg/mL
|
Solution for IV Infusion
|
-
|
Furen Pharmaceutical Group Co., Ltd
|
China
|
CLIDP Conversion
|
30 November 2022
|
15 May 2025
|
| View |
|
DRP-5487-01
|
Etoricoxib
|
Unbranded
|
90 mg
|
Film-Coated Tablet
|
Selective COX-2 Inhibitor
|
Zim Laboratories Ltd.
|
India
|
Renewal
|
16 May 2024
|
27 August 2029
|
| View |
|
DRP-5488-03
|
Etoricoxib
|
Unbranded
|
120 mg
|
Film-Coated Tablet
|
Selective COX-2 Inhibitor
|
Zim Laboratories Ltd.
|
India
|
Renewal
|
21 March 2024
|
27 August 2029
|