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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

AMITRIPTYLINE HYDROCHLORIDE

ANDANot in Orange Book

AMITRIPTYLINE HYDROCHLORIDE | A086011 | MYLAN

API Supply Chain5 active DMFs4 inactive

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

DIPHARMA FRANCIS SRLAMITRIPTYLINE HYDROCHLORIDE

DMF 29081977

RL FINE CHEM PVT LTDAMITRIPTYLINE HYDROCHLORIDE

DMF 181112005

SUN PHARMACEUTICAL INDUSTRIES LTDAMITRIPTYLINE HYDROCHLORIDE USP

DMF 195892006

VASUDHA PHARMA CHEM LTDAMITRIPTYLINE HYDROCHLORIDE USP

DMF 196352006

MANKIND PHARMA LTDAMITRIPTYLINE HYDROCHLORIDE USP

DMF 335652019

KV PHARMACEUTICAL COInactiveAMITRIPTYLINE HYDROCHLORIDE

DMF 24131975

EGIS PHARMACEUTICALS PRIVATE LTDInactiveAMITRIPTYLINE HYDROCHLORIDE

DMF 70591987

MERIND LTDInactiveAMITRIPTYLINE HYDROCHLORIDE USP

DMF 110271994

WANBURY LTDInactiveAMITRIPTYLINE

DMF 181742005

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

Products (1)

#001 — 75MG

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TABLET; ORAL | Approved: Apr. 10, 1978

No patent or exclusivity listings for this strength.