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FDA Orange Book · active-ingredient family

Chlorpheniramine maleate

Chlorpheniramine maleate is approved as 6 brand and 34 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CHLOR-TRIMETON · NDA 007638

6

Brand (NDA)

34

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, injectable, syrup, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
CHLOR-TRIMETONRLD×2BAYER HEALTHCARE LLCNDA 007638—Approved Prior to Jan 1, 1982
EFIDAC 24 CHLORPHENIRAMINE MALEATEALZANDA 019746—Nov 18, 1994
TELDRIN×2GLAXOSMITHKLINENDA 017369—Approved Prior to Jan 1, 1982
CHLOR-TRIMETONSCHERING PLOUGHNDA 008826—Approved Prior to Jan 1, 1982
CHLOR-TRIMETONSCHERING PLOUGHNDA 008794—Approved Prior to Jan 1, 1982
CHLOR-TRIMETON×2SCHERINGNDA 006921—Approved Prior to Jan 1, 1982

Generic (ANDA) products (34)

ProductApplicantApplicationTEApproved
CHLORPHENIRAMINE MALEATEAVANTHI INCANDA 040829—May 13, 2009
CHLORPHENIRAMINE MALEATEAUROLIFE PHARMA LLCANDA 070797—Aug 12, 1988
CHLORPHENIRAMINE MALEATEPIONEER PHARMSANDA 088556—Jul 13, 1984
CHLORPHENIRAMINE MALEATEPHARM ASSOCANDA 087520—Feb 10, 1982
CHLORPHENIRAMINE MALEATEBEL MARANDA 080821—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEELKINS SINNANDA 080797—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEWATSON LABSANDA 083593—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEWATSON LABSANDA 086096—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEWATSON LABSANDA 086095—Approved Prior to Jan 1, 1982
PYRIDAMAL 100BEL MARANDA 083733—Approved Prior to Jan 1, 1982
ANTAGONATEBAYER PHARMSANDA 083381—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEANABOLICANDA 083078—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEAUROLIFE PHARMA LLCANDA 080961—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEBELL PHARMAANDA 083062—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEELKINS SINNANDA 080938—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEIMPAX LABSANDA 080809—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEIVAX SUB TEVA PHARMSANDA 080779—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEKV PHARMANDA 087164—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATELEDERLEANDA 086941—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATENEWTRON PHARMSANDA 086519—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEPANRAYANDA 083243—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEPHARMAVITEANDA 085104—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEPHARMERALANDA 083753—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEPUREPAC PHARMANDA 086306—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEPVT FORMANDA 080786—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEROXANEANDA 080626—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATESUN PHARM INDUSTRIESANDA 080700—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEVITARINEANDA 085837—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEWATSON LABSANDA 080696—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEWATSON LABSANDA 080791—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEWATSON LABSANDA 085139—Approved Prior to Jan 1, 1982
CHLORPHENIRAMINE MALEATEWEST WARDANDA 083787—Approved Prior to Jan 1, 1982
KLOROMINHALSEYANDA 083629—Approved Prior to Jan 1, 1982
PHENETRONLANNETTANDA 080846—Approved Prior to Jan 1, 1982

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.

Chlorpheniramine maleate — frequently asked questions

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

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