| View |
|
DR-XY48741
|
Pregabalin
|
Nurica
|
300 mg
|
Capsule
|
-
|
Macter International Ltd.
|
Pakistan
|
Initial
|
24 May 2023
|
24 May 2028
|
| View |
|
DRP-13941
|
Rifampicin + Isoniazid
|
Duasaph-450
|
450 mg/400 mg
|
Film-Coated Tablet
|
-
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial
|
22 May 2023
|
22 May 2028
|
| View |
|
DRP-13960
|
Rosuvastatin (As Calcium)
|
One-Rosu 20
|
20 mg
|
Film-Coated Tablet
|
-
|
Intas Pharmaceuticals Limited.
|
India
|
Initial
|
25 May 2023
|
25 May 2028
|
| View |
|
DRP-13889
|
Methylprednisolone (as sodium succinate)
|
Cortimep
|
40mg
|
Powder For Injection (IM/IV)
|
-
|
BCWorld Pharm. Co., Ltd.
|
Korea
|
Initial
|
23 May 2023
|
23 May 2028
|
| View |
|
DRP-13946
|
Leuprolide Acetate
|
Blirelin
|
3.75mg
|
Powder For Injection (IM/SC)
|
-
|
Dongkook Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
23 May 2023
|
23 May 2028
|
| View |
|
DRP-13955
|
Mupirocin
|
None
|
20 mg/g (2% w/w)
|
Topical Ointment
|
Antibacterial
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial
|
25 May 2023
|
25 May 2028
|
| View |
|
DRP-13956
|
Mupirocin
|
Adocin
|
2% w/w
|
Topical Ointment
|
Antibacterial
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial
|
25 May 2023
|
25 May 2028
|
| View |
|
DRHR-2257
|
Methyl Salicylate + Camphor + Menthol
|
Omega Pain Killer Liniment
|
157.75 mg/ 40 mg/ 33.30 mg per mL
|
Liniment
|
-
|
International Pharmaceuticals, Inc.
|
Philippines
|
Initial
|
24 May 2023
|
24 May 2025
|
| View |
|
DR-XY48747
|
Pomalidomide
|
Mulkasar
|
1 mg
|
Capsule
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Monitored Release
|
25 May 2023
|
28 May 2028
|
| View |
|
DR-XY48746
|
Pomalidomide
|
Mulkasar
|
2 mg
|
Capsule
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Monitored Release
|
25 May 2023
|
25 May 2028
|
| View |
|
DR-XY48743
|
Pomalidomide
|
Mulkasar
|
3 mg
|
Capsule
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Monitored Release
|
25 May 2023
|
25 May 2028
|
| View |
|
DR-XY48742
|
Pomalidomide
|
Mulkasar
|
4 mg
|
Capsule
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Monitored Release
|
24 May 2023
|
24 May 2028
|
| View |
|
DR-XY48739
|
Ascorbic Acid
|
Fern-C Extra Strength
|
1g (equivalent to 1.125g Sodium Ascorbate)
|
Tablet
|
-
|
Compact Pharmaceuticals, Corp.
|
Philippines
|
Initial
|
24 May 2023
|
24 May 2028
|
| View |
|
DRHR-2256
|
Methyl Salicylate + Camphor + Menthol
|
Methylin
|
17 mg / 6 mg / 4 mg per 100 mg
|
Liniment
|
-
|
Telstar Manufacturing Corporation
|
Philippines
|
Initial
|
24 May 2023
|
24 May 2028
|
| View |
|
DRP-13978
|
Olanzapine
|
Lanzaph
|
20 mg
|
Orally Disintegrating Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
29 May 2023
|
29 May 2028
|
| View |
|
FDA-0592541
|
Florfenicol (Vet.)
|
Selectan
|
300mg/mL
|
Solution For Injection (IM)
|
-
|
Laboratorios Hipra S.A.
|
Spain
|
Initial (Vet.)
|
22 May 2023
|
22 May 2028
|
| View |
|
DRHR-2253
|
Petroleum Jelly
|
None
|
1g/g Ointment
|
Ointment
|
-
|
J. Chemie Laboratories, Inc.
|
Philippines
|
Initial
|
24 May 2023
|
24 May 2025
|
| View |
|
DRHR-2255
|
Petroleum Jelly
|
SM Bonus-PJU
|
1g/g
|
Ointment
|
-
|
J. Chemie Laboratories, Inc.
|
Philippines
|
Initial
|
24 May 2023
|
24 May 2025
|
| View |
|
DRHR-2254
|
Petroleum Jelly
|
None
|
1g/g
|
Ointment
|
-
|
J. Chemie Laboratories, Inc.
|
Philippines
|
Initial
|
24 May 2023
|
24 May 2026
|
| View |
|
DR-XY48748
|
Cholecalciferol (Vitamin D3)+ Minerals
|
Calvin Plus
|
Each film-coated tablet contains:
Cholecalciferol (Vitamin D1)
Calcium (equivalent to 1500 mg Calcium Carbonate) Magnesium (equivalent to 66.31 mg Magnesium Oxide) Zinc (equivalent to 9.34 mg Zinc Oxide)
200 IU
600 mg
40 mg
7.5 mg
Manganese (equivalent to 5.54 mg Manganese sulfate) Copper (equivalent to 1.25 mg Copper Oxide) Boron (equivalent to 2.2 mg Sodium Borate)
1.8 mg
I mg
250 mcg
|
Film Coated Tablet
|
-
|
Biolab Co., Ltd.
|
Thailand
|
Initial (Correction)
|
04 October 2023
|
25 May 2028
|