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FDA Orange Book · active-ingredient family

Carbinoxamine maleate

Carbinoxamine maleate is approved as 3 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:KARBINAL ER · NDA 022556

3

Brand (NDA)

10

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · elixir, solution, suspension, extended release, tablet

ProductApplicantApplicationTEApproved
KARBINAL ERRLDAYTUNDA 022556—Mar 28, 2013
CLISTINRLDMCNEILNDA 008955—Approved Prior to Jan 1, 1982
CLISTINRLDORTHO MCNEIL PHARMNDA 008915—Approved Prior to Jan 1, 1982

Generic (ANDA) products (10)

ProductApplicantApplicationTEApproved
CARBINOXAMINE MALEATELEADINGANDA 215476AADec 19, 2024
CARBINOXAMINE MALEATEMIKARTANDA 207484AAMay 31, 2016
CARBINOXAMINE MALEATEMISSION PHARMACALANDA 090756AAMay 27, 2011
CARBINOXAMINE MALEATECYPRESS PHARMANDA 090417—Aug 23, 2010
CARBINOXAMINE MALEATECYPRESS PHARMANDA 090418—May 04, 2010
CARBINOXAMINE MALEATESENORES PHARMSANDA 090435—Apr 15, 2010
CARBINOXAMINE MALEATESTRIDES PHARMA INTLANDA 040639—May 30, 2008
CARBINOXAMINE MALEATEPH HEALTHANDA 040814—Feb 26, 2008
CARBINOXAMINE MALEATEGENUSANDA 040458—Apr 25, 2003
CARBINOXAMINE MALEATEGENUSANDA 040442AAMar 19, 2003

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9522191Jun 15, 2027in 1 yr
Product
8062667Mar 29, 2029in 2 yr 10 mo
Product

Carbinoxamine maleate — frequently asked questions

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

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