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ENDEP

ANDA

AMITRIPTYLINE HYDROCHLORIDE | A085749 | HOFFMANN LA ROCHE INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2022-P-0068 · 5 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. sections 314.122 and 314.161 requesting that the FDA determine whether ENDEP (amitriptyline HCl) Oral Concentrate, 40 mg/mL, approved under ANDA	505(q)	2022-01-11	Granted	HYMAN, PHELPS & MCNAMARA, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

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#001 — 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CONCENTRATE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.