Viewing data from:

ZALEPLON

ANDA

ZALEPLON | A078095 | UPSHER SMITH LABORATORIES LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs8 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVZALEPLON

DMF 175652004

APITORIA PHARMA PRIVATE LTDZALEPLON USP

DMF 193982006

ORBION PHARMACEUTICALS PRIVATE LTDZALEPLON

DMF 208772007

CENTAUR PHARMACEUTICALS PVT LTDZALEPLON USP

DMF 275682013

ZACH SYSTEM SPAInactiveZALEPLON

DMF 117471995

AMINO CHEMICALS LTDInactiveZALEPLON

DMF 167852003

MEDICHEM SAInactiveZALEPLON

DMF 172302004

CIPLA LTDInactiveZALEPLON

DMF 180222005

GADOR SAInactiveZALEPLON

DMF 190152005

MEDICHEM MANUFACTURING (MALTA) LTDInactiveZALEPLON (MED - 201970)

DMF 194632006

CADILA HEALTHCARE LTDInactiveZALEPLON

DMF 214822008

APOTEX PHARMACHEM INCInactiveZALEPLON

DMF 225722009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 10, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 6, 2008

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 6, 2008