Viewing data from:

DOXEPIN HYDROCHLORIDE

ANDA

DOXEPIN HYDROCHLORIDE | A215408 | TEVA PHARMACEUTICALS DEVELOPMENT INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ZONALON(TE code: AB)

API Supply Chain4 active DMFs2 inactive

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

OLON SPADOXEPIN HYDROCHLORIDE

DMF 50251983

MSN LIFE SCIENCES PRIVATE LTDDOXEPIN HYDROCHLORIDE USP

DMF 335592019

R L FINE CHEM PVT LTDDOXEPIN HYDROCHLORIDE

DMF 344382020

RAKS PHARMA PVT LTDDOXEPIN HYDROCHLORIDE USP

DMF 350172020

BOEHRINGER MANNHEIM GMBHInactiveDOXEPIN

DMF 24101975

GANES CHEMICALS INC PENNSVILLE DIVInactiveDOXEPIN HYDROCHLORIDE

DMF 68561987

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 14, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Feb 17, 2023

No patent or exclusivity listings for this strength.