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PAMINE

NDA

METHSCOPOLAMINE BROMIDE | N008848 | FOUGERA PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 18, 2005	SUPPL -25	View Letter (PDF)
Jun 14, 2004	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 25, 2003