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BENZTROPINE MESYLATE

ANDA

BENZTROPINE MESYLATE | A089058 | PLIVA INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2018-P-2720 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA amend the Orange Book to designate ANDA 204713 (or another appropriate ANDA) as an additional Reference Standard for Benztropine Mesylate Tablets in 0.5 mg, 1 mg, and 2 mg strengths, because the current reference stan	505(q)	2018-07-13	Open	Hyman, Phelps & McNamara, P.C.

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

API Supply Chain8 active DMFs1 inactive

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

FINE CHEMICALS CORP PTY LTDBENZTROPINE MESYLATE

DMF 69141987

DR REDDYS LABORATORIES LTDBENZTROPINE MESYLATE USP

DMF 70331987

ARCH PHARMALABS LTDBENZTROPINE MESYLATE USP

DMF 237192010

SIEGFRIED GRAFTON INCBENZTROPINE MESYLATE

DMF 288402015

NAVINTA LLCBENZTROPINE MESYLATE USP

DMF 321362018

HARMAN FINOCHEM LTDBENZTROPINE MESYLATE USP

DMF 331262018

ESCIENTIA ADVANCED SCIENCES PRIVATE LTDBENZTROPINE MESYLATE USP

DMF 334802019

KALINTIS HEALTHCARE PVT LTDBENZTROPINE MESYLATE USP

DMF 349642020

ORION CORP LTDInactiveBENZTROPINE MESYLATE

DMF 61891986

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

Products (1)

#001 — 0.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 10, 1988

No patent or exclusivity listings for this strength.