| View |
|
DR-XY48732
|
Pregabalin
|
Zonik
|
50 mg
|
Capsule
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
19 May 2023
|
19 May 2028
|
| View |
|
DR-XY48733
|
Pregabalin
|
Zonik
|
25 mg
|
Capsule
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
19 May 2023
|
19 May 2028
|
| View |
|
DR-XY48735
|
Pomalidomide
|
Pomalid 3
|
3 mg
|
Capsule
|
-
|
Natco Pharma Limited - Pharma Division (Unit IV and V)
|
India
|
Monitored Release
|
17 May 2023
|
19 May 2028
|
| View |
|
DR-XY48736
|
Pomalidomide
|
Pomalid 2
|
2 mg
|
Capsules
|
-
|
Natco Pharma Limited - Pharma Division (Unit IV and V)
|
India
|
Monitored Release
|
19 May 2023
|
19 May 2028
|
| View |
|
DR-XY48737
|
Pomalidomide
|
Pomalid 1
|
1 mg
|
Capsules
|
-
|
Natco Pharma Limited - Pharma Division (Unit IV and V)
|
India
|
Monitored Release
|
19 May 2023
|
19 May 2028
|
| View |
DR-XY48738_PI_01.pdf
|
DR-XY48738
|
Amoxicillin (as trihydrate)
|
Sitimox
|
500 mg
|
Capsule
|
-
|
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd
|
China
|
Initial (Re-Application)
|
22 May 2023
|
22 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 |
|
DR-XY4874
|
Pomalidomide
|
Pomalid 4
|
4 mg
|
Capsule
|
-
|
Natco Pharma Limited Pharma Division (Unit IV and V)
|
India
|
Monitored Release
|
19 May 2023
|
19 May 2028
|
| View |
|
DR-XY48740
|
Roflumilast
|
Rafair
|
500 mcg
|
Tablet
|
-
|
Zydus Lifesciences Limited
|
India
|
Initial
|
04 May 2023
|
24 May 2028
|
| View |
|
DR-XY48741
|
Pregabalin
|
Nurica
|
300 mg
|
Capsule
|
-
|
Macter International Ltd.
|
Pakistan
|
Initial
|
24 May 2023
|
24 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-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-XY48744_PI_01.pdf
|
DR-XY48744
|
Labetalol Hydrochloride
|
Betalex
|
5 mg/mL (20 mg/4 mL)
|
Solution for Injection (IV)
|
-
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
25 May 2023
|
25 May 2028
|
| View |
|
DR-XY48745
|
Cilostazol
|
Cilostan Cr
|
100 mg
|
Controlled-Release Tablet
|
-
|
Korea United Pharm. Inc.
|
Korea
|
Initial
|
05 June 2023
|
05 June 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-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-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
|
| View |
|
DR-XY48749
|
Mometasone Furoate
|
Momevex
|
1mg/g 0.1% w/w
|
Cream
|
-
|
Yash Pharmaceuticals
|
India
|
Initial
|
26 May 2023
|
26 May 2028
|
| View |
|
DR-XY48750
|
Tenofovir disoproxil fumarate + Lamivudine
Efavirenz
|
Avonza
|
300mg/300mg/400mg
|
Film-Coated Tablet
|
-
|
Mylan Laboratories Limited.
|
India
|
Monitored Release (MR) (Re-application)
|
26 May 2023
|
26 May 2028
|
| View |
|
DR-XY48751
|
Vildagliptin
|
Vildanorm
|
50 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 May 2023
|
26 May 2028
|