Details for New Drug Application (NDA): 204054
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NDA 204054 describes MECAMYLAMINE HYDROCHLORIDE, which is a drug marketed by Lgm Pharma and is included in one NDA. It is available from two 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. Two suppliers are listed for this compound. 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. Two suppliers are listed for this compound. Additional details are available on the mecamylamine hydrochloride profile page.
Summary for 204054
| Tradename: | MECAMYLAMINE HYDROCHLORIDE |
| Applicant: | Lgm Pharma |
| Ingredient: | mecamylamine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204054
| Physiological Effect | Decreased Autonomic Ganglionic Activity |
Medical Subject Heading (MeSH) Categories for 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 | Vyera Pharmaceuticals, LLC | 69413-558 | 69413-558-40 | 100 TABLET in 1 BOTTLE (69413-558-40) |
| MECAMYLAMINE HYDROCHLORIDE | mecamylamine hydrochloride | TABLET;ORAL | 204054 | ANDA | LGM PHARMA SOLUTIONS, LLC | 79739-7183 | 79739-7183-1 | 100 TABLET in 1 BOTTLE (79739-7183-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Mar 19, 2013 | TE: | RLD: | No | |||||
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