FDA Orange Book · active-ingredient family
Mecamylamine hydrochloride
Mecamylamine hydrochloride: 1 brand, 1 generic; first approved Mar 19, 2013; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
0
Presentations
2
Brand (NDA) products
Originator applications
- INVERSINERLDTARGACEPTNDA 010251—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued —
Generic (ANDA) products (1)
Abbreviated applications
- MECAMYLAMINE HYDROCHLORIDERSLGM PHARMAANDA 2040542013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
13 yr 9 mo ago
Most recent approval
13 yr 9 mo ago
All 2 applications were approved in 2013.
Brand (NDA) 150%
Generic (ANDA) 150%
Mecamylamine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
