| View |
|
DR-XY48691
|
Mometasone furoate (as monohydrate)
|
Momenex
|
50 mcg/actuation
|
aqueous nasal spray
|
-
|
Synmosa Biopharma Corporation (Synmosa Plant)
|
Taiwan
|
Initial
|
05 April 2023
|
05 April 2028
|
| View |
|
DR-XY48692
|
Mupirocin
|
Mupizee
|
20 mg/g (2% w/w)
|
Ointment
|
-
|
Zee Laboratories Limited
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
DR-XY48693
|
Ascorbic Acid + Zinc
|
Neo-Cee Plus
|
600 mg (equivalent to 675 mg Sodium Ascorbate) / 10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Compact Pharmaceuticals, Corp.
|
Philippines
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
DR-XY48694_PI_01.pdf
|
DR-XY48694
|
Brexpiprazole
|
Rexulti
|
4 mg
|
Film-Coated Tablet
|
-
|
Korea Otsuka Pharmaceutical Co., Ltd.
|
Korea
|
Monitored Release
|
13 April 2023
|
13 April 2028
|
| View |
DR-XY48695_PI_01.pdf
|
DR-XY48695
|
Brexpiprazole
|
Rexulti
|
3 mg
|
Film Coated Tablet
|
-
|
Korea Otsuka Pharmaceutical Co., Ltd
|
Korea
|
Monitored Release
|
13 April 2023
|
13 April 2028
|
| View |
DR-XY48696_PI_01.pdf
|
DR-XY48696
|
Brexpiprazole
|
Rexulti
|
2 mg
|
Film-Coated Tablet
|
-
|
Korea Otsuka Pharmaceutical Co., Ltd.
|
Korea
|
Monitored Release
|
13 April 2023
|
13 April 2028
|
| View |
DR-XY48697_PI_01.pdf
|
DR-XY48697
|
Brexpiprazole
|
Rexulti
|
1 mg
|
Film-Coated Tablet
|
-
|
Korea Otsuka Pharmaceutical Co., Ltd.
|
Korea
|
Monitored Release
|
13 April 2023
|
13 April 2028
|
| View |
|
DR-XY48698
|
Apixaban
|
Apxia
|
2.5 mg
|
Film Coated Tablet
|
-
|
Micro Labs Limited
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
DR-XY48699
|
Apixaban
|
Apxia
|
5 mg
|
Film Coated Tablet
|
-
|
Micro Labs Limited
|
India
|
Initial
|
13 April 2023
|
13 April 2028
|
| View |
|
DR-XY48700
|
Prednicarbate
|
Peitel
|
250 mcg/g (0.25% w/w)
|
Topical Cream
|
-
|
Ferrer Internacional, S.A.
|
Spain
|
Monitored Release
|
14 April 2023
|
14 April 2028
|
| View |
|
DR-XY48701
|
Ascorbic Acid + Zinc
|
Jewel-Zee Plus
|
500 mg/40 mg
|
Capsule
|
-
|
Ashford Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial [OTC]
|
19 April 2023
|
19 April 2028
|
| View |
|
DR-XY48702
|
Loratadine + Betamethasone
|
Claricort
|
5 mg/250 mcg
|
Tablet
|
-
|
Eurofarma Argentina S.A.
|
Argentine Republic
|
Initial
|
14 April 2023
|
14 April 2028
|
| View |
|
DR-XY48703
|
Midazolam
|
Midamarc
|
5 mg/mL (15 mg/3 mL)
|
Solution for Injection
(IM/IV/Rectal)
|
-
|
HBM Pharma s.r.o.
|
Slovak Republic
|
Initial
|
14 April 2023
|
14 April 2028
|
| View |
|
DR-XY48704
|
Teneligliptin (as hydrobromide hydrate)
|
None
|
20 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Monitored Release (Re-application)
|
20 April 2023
|
20 April 2026
|
| View |
|
DR-XY48705
|
Zinc
|
RemZnc
|
20 mg (equivalent to 57.645 mg Zinc Sulfate Monohydrate)
|
Tablet
|
-
|
The IBN Sina Pharmaceutical Industry Ltd.
|
Bangladesh
|
Initial [OTC]
|
20 April 2023
|
20 April 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 |
DR-XY48708_PI_01.pdf
|
DR-XY48708
|
Dacomitinib (as monohydrate)
|
Vizimpro
|
45 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Epidermal Growth Factor Receptor (EGFR) Tyrosine kinase Inhibitor)
|
Pfizer Manufacturing Deutschland GMBH
|
Germany
|
Monitored Release (MR) (Corrections)
|
13 February 2024
|
25 April 2028
|
| View |
DR-XY48709_PI_01.pdf
|
DR-XY48709
|
Dacomitinib (as monohydrate)
|
Vizimpro
|
15 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Epidermal Growth Receptor (EGFR) Tyrosine kinase Inhibitor)
|
Pfizer Manufacturing Deutschland GMBH
|
Germany
|
Monitored Release (MR) (Corrections)
|
13 February 2024
|
25 April 2028
|
| View |
DR-XY48710_PI_01.pdf
|
DR-XY48710
|
Dacomitinib (as monohydrate)
|
Vizimpro
|
30 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Epidermal Growth Factor Receptor (EGFR) Tyrosine kinase Inhibitor)
|
Pfizer Manufacturing Deutschland GMBH
|
Germany
|
Monitored Release (MR) (Corrections)
|
13 February 2024
|
25 April 2028
|