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FDA Orange Book · active-ingredient family

Cyproheptadine hydrochloride

Cyproheptadine hydrochloride is approved as 2 brand and 39 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PERIACTIN · NDA 013220

2

Brand (NDA)

39

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · syrup, tablet

ProductApplicantApplicationTEApproved
PERIACTINRLDMERCKNDA 013220—Approved Prior to Jan 1, 1982
PERIACTINRLDMERCKNDA 012649—Approved Prior to Jan 1, 1982

Generic (ANDA) products (39)

ProductApplicantApplicationTEApproved
CYPROHEPTADINE HYDROCHLORIDETRIS PHARMA INCANDA 205431—Dec 21, 2021
CYPROHEPTADINE HYDROCHLORIDEQUAGENANDA 212491AAFeb 24, 2021
CYPROHEPTADINE HYDROCHLORIDEQUAGENANDA 212423AAMay 22, 2019
CYPROHEPTADINE HYDROCHLORIDEREGCON HOLDINGSANDA 206676AAApr 12, 2019
CYPROHEPTADINE HYDROCHLORIDEST JOHN PHARMANDA 209108AAOct 16, 2018
CYPROHEPTADINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 209172AAApr 11, 2018
CYPROHEPTADINE HYDROCHLORIDECHARTWELL MOLECULARANDA 203191AAJul 13, 2017
CYPROHEPTADINE HYDROCHLORIDEZYDUS PHARMSANDA 208938AAMay 19, 2017
CYPROHEPTADINE HYDROCHLORIDERISINGANDA 207555AAJan 31, 2017
CYPROHEPTADINE HYDROCHLORIDERISINGANDA 207783—Dec 29, 2016
CYPROHEPTADINE HYDROCHLORIDEPATRINANDA 204823—Dec 27, 2016
CYPROHEPTADINE HYDROCHLORIDEAPPCOANDA 206553AANov 29, 2016
CYPROHEPTADINE HYDROCHLORIDEINGENUS PHARMS LLCANDA 205087AASep 23, 2015
CYPROHEPTADINE HYDROCHLORIDEPHARM ASSOCANDA 091295—Mar 28, 2013
CYPROHEPTADINE HYDROCHLORIDERISINGANDA 040668AAJun 28, 2006
CYPROHEPTADINE HYDROCHLORIDEKENTONANDA 040644AAMay 30, 2006
CYPROHEPTADINE HYDROCHLORIDEMOUNTAINANDA 040537AASep 30, 2003
CYPROHEPTADINE HYDROCHLORIDENASKAANDA 089021—Dec 21, 1987
CYPROHEPTADINE HYDROCHLORIDEHALSEYANDA 089199—Jul 03, 1986
CYPROHEPTADINE HYDROCHLORIDEHALSEYANDA 089057—Jul 03, 1986
CYPROHEPTADINE HYDROCHLORIDEAM THERAPANDA 088798—Feb 15, 1985
CYPROHEPTADINE HYDROCHLORIDEPIONEER PHARMSANDA 087839—Feb 08, 1984
CYPROHEPTADINE HYDROCHLORIDEDURAMED PHARMS BARRANDA 088232—Oct 25, 1983
CYPROHEPTADINE HYDROCHLORIDEPLIVAANDA 088205—Jul 26, 1983
CYPROHEPTADINE HYDROCHLORIDECHARTWELL RXANDA 088212AAMay 26, 1983
CYPROHEPTADINE HYDROCHLORIDEMD PHARMANDA 087566—Nov 10, 1982
CYPROHEPTADINE HYDROCHLORIDEMORTON GROVEANDA 087001—Nov 04, 1982
CYPROHEPTADINE HYDROCHLORIDEASCOTANDA 087685—Oct 25, 1982
CYPROHEPTADINE HYDROCHLORIDERLDACTAVIS MID ATLANTICANDA 086833—Approved Prior to Jan 1, 1982
CYPROHEPTADINE HYDROCHLORIDEANVIANDA 087129—Approved Prior to Jan 1, 1982
CYPROHEPTADINE HYDROCHLORIDECHARTWELL RXANDA 086808—Approved Prior to Jan 1, 1982
CYPROHEPTADINE HYDROCHLORIDERLDHERITAGE PHARMAANDA 087056—Approved Prior to Jan 1, 1982
CYPROHEPTADINE HYDROCHLORIDEKV PHARMANDA 086737—Approved Prior to Jan 1, 1982
CYPROHEPTADINE HYDROCHLORIDEMYLANANDA 086678—Approved Prior to Jan 1, 1982
CYPROHEPTADINE HYDROCHLORIDESUPERPHARMANDA 087405—Approved Prior to Jan 1, 1982
CYPROHEPTADINE HYDROCHLORIDEVITARINEANDA 087284—Approved Prior to Jan 1, 1982
CYPROHEPTADINE HYDROCHLORIDEWATSON LABSANDA 085245—Approved Prior to Jan 1, 1982
CYPROHEPTADINE HYDROCHLORIDEWATSON LABSANDA 086165—Approved Prior to Jan 1, 1982
CYPROHEPTADINE HYDROCHLORIDEWATSON LABSANDA 086580—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.

Cyproheptadine hydrochloride — frequently asked questions

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

Agent CTA Background

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