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Details for New Drug Application (NDA): 204054

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NDA 204054 describes MECAMYLAMINE HYDROCHLORIDE, which is a drug marketed by Nexgen Pharma and is included in one NDA. It is available from three suppliers. Additional details are available on the MECAMYLAMINE HYDROCHLORIDE profile page.

The generic ingredient in MECAMYLAMINE HYDROCHLORIDE is mecamylamine hydrochloride. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mecamylamine hydrochloride profile page.

Summary for NDA: 204054

Tradename:
MECAMYLAMINE HYDROCHLORIDE
Applicant:
Nexgen Pharma
Ingredient:
mecamylamine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204054

Suppliers and Packaging for NDA: 204054

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MECAMYLAMINE HYDROCHLORIDE
mecamylamine hydrochloride
TABLET;ORAL 204054 ANDA Nexgen Pharma, Inc. 0722-7183 0722-7183-01 100 TABLET in 1 BOTTLE (0722-7183-01)
MECAMYLAMINE HYDROCHLORIDE
mecamylamine hydrochloride
TABLET;ORAL 204054 ANDA Manchester Pharmaceuticals 45043-558 45043-558-40 100 TABLET in 1 BOTTLE (45043-558-40)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Mar 19, 2013TE:RLD:No


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