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METHSCOPOLAMINE BROMIDE

ANDA

METHSCOPOLAMINE BROMIDE | A040624 | CHARTWELL RX SCIENCES LLC

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Kulkarni Law Firm FDA-2019-P-0537 · 4 docket documents Darshan Kulkarni, Esq. of The Kulkarni Law Firm filed this citizen petition requesting that FDA's Office of Generic Drugs ensure all active pharmaceutical ingredient and finished product manufacturers of Methscopolamine Bromide tablets consistently comply with USP standards and the 2016 FDA Guidance	Other	2019-02-04	Denied	Kulkarni Law Firm

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

API Supply Chain3 active DMFs2 inactive

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

PHYTEX AUSTRALIA PVT LTDMETHSCOPOLAMINE BROMIDE

DMF 74101988

ALKALOIDS PRIVATE LTDMETHSCOPOLAMINE BROMIDE

DMF 286292014

ALCHEM INTERNATIONAL PRIVATE LTDMETHSCOPOLAMINE BROMIDE USP

DMF 298052015

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveMETHSCOPOLAMINE BROMIDE

DMF 180692005

VITAL LABORATORIES PVT LTDInactiveMETHSCOPOLAMINE BROMIDE

DMF 309622016

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

Products (2)

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#001 — 2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 28, 2006

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 28, 2006