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FDA Orange Book · active-ingredient family

Mecamylamine hydrochloride

Mecamylamine hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:INVERSINE · NDA 010251

1

Brand (NDA)

1

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
INVERSINERLDTARGACEPTNDA 010251Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
MECAMYLAMINE HYDROCHLORIDELGM PHARMAANDA 204054Mar 19, 2013

Listed patents

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.

Mecamylamine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.