| 64239-112-02 |
64239-112 |
HUMAN OTC DRUG |
Esomeprazole |
Esomeprazole |
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
ORAL |
20240412 |
N/A |
NDA |
NDA214278 |
Dexcel Pharma Technologies Ltd |
ESOMEPRAZOLE |
20 mg/1 |
2 BLISTER PACK in 1 CARTON (64239-112-02) / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| 64239-112-03 |
64239-112 |
HUMAN OTC DRUG |
Esomeprazole |
Esomeprazole |
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
ORAL |
20240412 |
N/A |
NDA |
NDA214278 |
Dexcel Pharma Technologies Ltd |
ESOMEPRAZOLE |
20 mg/1 |
2 CARTON in 1 CARTON (64239-112-03) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| 64239-112-04 |
64239-112 |
HUMAN OTC DRUG |
Esomeprazole |
Esomeprazole |
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
ORAL |
20240412 |
N/A |
NDA |
NDA214278 |
Dexcel Pharma Technologies Ltd |
ESOMEPRAZOLE |
20 mg/1 |
3 CARTON in 1 CARTON (64239-112-04) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| 64239-112-05 |
64239-112 |
HUMAN OTC DRUG |
Esomeprazole |
Esomeprazole |
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
ORAL |
20240412 |
N/A |
NDA |
NDA214278 |
Dexcel Pharma Technologies Ltd |
ESOMEPRAZOLE |
20 mg/1 |
1 BLISTER PACK in 1 CARTON (64239-112-05) / 2 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| 64239-112-07 |
64239-112 |
HUMAN OTC DRUG |
Esomeprazole |
Esomeprazole |
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
ORAL |
20240412 |
N/A |
NDA |
NDA214278 |
Dexcel Pharma Technologies Ltd |
ESOMEPRAZOLE |
20 mg/1 |
2 BLISTER PACK in 1 CARTON (64239-112-07) / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| 64239-112-08 |
64239-112 |
HUMAN OTC DRUG |
Esomeprazole |
Esomeprazole |
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
ORAL |
20240412 |
N/A |
NDA |
NDA214278 |
Dexcel Pharma Technologies Ltd |
ESOMEPRAZOLE |
20 mg/1 |
2 CARTON in 1 CARTON (64239-112-08) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| 64239-112-09 |
64239-112 |
HUMAN OTC DRUG |
Esomeprazole |
Esomeprazole |
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
ORAL |
20240412 |
N/A |
NDA |
NDA214278 |
Dexcel Pharma Technologies Ltd |
ESOMEPRAZOLE |
20 mg/1 |
3 CARTON in 1 CARTON (64239-112-09) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| 64239-112-10 |
64239-112 |
HUMAN OTC DRUG |
Esomeprazole |
Esomeprazole |
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
ORAL |
20240412 |
N/A |
NDA |
NDA214278 |
Dexcel Pharma Technologies Ltd |
ESOMEPRAZOLE |
20 mg/1 |
1 BLISTER PACK in 1 CARTON (64239-112-10) / 2 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |