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DOXEPIN HYDROCHLORIDE

ANDA

DOXEPIN HYDROCHLORIDE | A202761 | ZYDUS LIFESCIENCES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SILENOR(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.

Products (2)

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#001 — EQ 3MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 16, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 6MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 16, 2023