Details for New Drug Application (NDA): 200602

NDA 200602 describes METHSCOPOLAMINE BROMIDE, which is a drug marketed by Bayshore Pharms Llc, Breckenridge Pharm, Chartwell Rx, Ne Rx Pharma, and Pvt Form, and is included in five NDAs. It is available from four suppliers. Additional details are available on the METHSCOPOLAMINE BROMIDE profile page.

The generic ingredient in METHSCOPOLAMINE BROMIDE is methscopolamine bromide. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methscopolamine bromide profile page.

Summary for 200602

Tradename:	METHSCOPOLAMINE BROMIDE
Applicant:	Bayshore Pharms Llc
Ingredient:	methscopolamine bromide
Patents:	0

Pharmacology for NDA: 200602

Mechanism of Action

Cholinergic Antagonists

Suppliers and Packaging for NDA: 200602

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHSCOPOLAMINE BROMIDE	methscopolamine bromide	TABLET;ORAL	200602	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-740	43063-740-01	100 TABLET in 1 BOTTLE, PLASTIC (43063-740-01)
METHSCOPOLAMINE BROMIDE	methscopolamine bromide	TABLET;ORAL	200602	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-741	43063-741-60	60 TABLET in 1 BOTTLE, PLASTIC (43063-741-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Sep 24, 2012	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 24, 2012	TE:	AA	RLD:	No

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