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FDA Orange Book · active-ingredient family

Homatropine methylbromide; hydrocodone bitartrate

Homatropine methylbromide; hydrocodone bitartrate is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HYCODAN · NDA 005213

1

Brand (NDA)

14

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · syrup, tablet

ProductApplicantApplicationTEApproved
HYCODANRLD×2GENUSNDA 005213AAJul 26, 1988

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDESANKALP LIFECAREANDA 210663—Jun 11, 2019
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATEAVANTHI INCANDA 207176AAAug 07, 2017
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDESCIEGEN PHARMSANDA 204765—Mar 06, 2017
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEABHAI LLCANDA 207487AAFeb 21, 2017
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEPADAGIS USANDA 205731—Feb 15, 2017
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDENOVEL LABS INCANDA 203535AAFeb 13, 2017
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATENOVEL LABS INCANDA 091528—Apr 20, 2011
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGENUS LIFESCIENCESANDA 040613—Feb 08, 2008
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATEACTAVIS ELIZABETHANDA 040295—Dec 01, 2000
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEIVAX SUB TEVA PHARMSANDA 040285—Jul 19, 1999
TUSSIGONKING PHARMSANDA 088508—Jul 30, 1985
HYDROPANEHALSEYANDA 088066—Jun 28, 1985
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEACTAVIS MID ATLANTICANDA 088017AAJul 05, 1983
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEPHARMOBEDIENTANDA 088008AAMar 03, 1983

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.

Homatropine methylbromide; hydrocodone bitartrate — frequently asked questions

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

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