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ANDA

HOMATROPINE METHYLBROMIDE | A086310 | MISSION PHARMACAL CO

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0004 Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Hydrocodone Bitartrate and Homatropine Methylbromide Syrup at a lower strength of 2.5 mg/0.75 mg per 5 mL suitable for submission as an abbreviated new drug application, with the reference lis	Other	2008-05-13	Granted	Lachman Consultant Services

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

API Supply Chain3 active DMFs1 inactive

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

SCL LIFESCIENCES LIMITEDHOMATROPINE METHYLBROMIDE USP

DMF 239632010

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDHOMATROPINE METHYLBROMIDE

DMF 285302014

C-SQUARED PHARMA LTDHOMATROPINE METHYLBROMIDE USP

DMF 310862016

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveHOMATROPINE METHYLBROMIDE

DMF 54411984

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

Products (1)

#001 — 3MG

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.