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CYCLOBENZAPRINE HYDROCHLORIDE

ANDA

CYCLOBENZAPRINE HYDROCHLORIDE | A072854 | AIPING PHARMACEUTICAL INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs5 inactive

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

HETERO DRUGS LTDCYCLOBENZAPRINE HYDROCHLORIDE

DMF 213922008

DERIVADOS QUIMICOS SAUCYCLOBENZAPRINE HYDROCHLORIDE

DMF 235212010

JUBILANT PHARMOVA LTDCYCLOBENZAPRINE HYDROCHLORIDE

DMF 247192011

MACLEODS PHARMACEUTICALS LTDCYCLOBENZAPRINE HYDROCHLORIDE EXTENDED RELEASE PELLETS

DMF 299552015

RL FINE CHEM PVT LTDCYCLOBENZAPRINE HYDROCHLORIDE

DMF 331472018

UNICHEM LABORATORIES LTDCYCLOBENZAPRINE HYDROCHLORIDE USP

DMF 346542020

GANES CHEMICALS INC PENNSVILLE DIVInactiveCYCLOBENZAPRINE HYDROCHLORIDE

DMF 58101985

SUMIKA FINE CHEMICALS CO LTDInactiveCYCLOBENZAPRINE HYDROCHLORIDE

DMF 80651989

SIFAVITOR SRLInactiveCYCLOBENZAPRINE HYDROCHLORIDE

DMF 95101992

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveCYCLOBENZAPRINE HYDROCHLORIDE

DMF 183172005

FLEMING LABORATORIES LTDInactiveCYCLOBENZAPRINE HYDROCHLORIDE USP BULK

DMF 230632009

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

Products (3)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 19, 1991

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 3, 2006

#003 — 7.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 13, 2026

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

AIPING PHARM INC received FDA approval for cyclobenzaprine hydrochloride (NDA 072854, supplement 003).

New: New record