FDA Orange Book · active-ingredient family
Cyproheptadine hydrochloride
Cyproheptadine hydrochloride: 2 brands, 39 generics; first approved Oct 25, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 39 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
39
Listed patents
0
Presentations
41
Brand (NDA) products
Originator applications
Generic (ANDA) products (39)
Abbreviated applications
- CYPROHEPTADINE HYDROCHLORIDETRIS PHARMA INCANDA 2054312021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEQUAGENANDA 2124912021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDEQUAGENANDA 2124232019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDEREGCON HOLDINGSANDA 2066762019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDEST JOHN PHARMANDA 2091082018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 2091722018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDECHARTWELL MOLECULARANDA 2031912017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDERSZYDUS PHARMSANDA 2089382017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDERISINGANDA 2075552017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDERISINGANDA 2077832016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEPATRINANDA 2048232016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEAPPCOANDA 2065532016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDEINGENUS PHARMS LLCANDA 2050872015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDEPHARM ASSOCANDA 0912952013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDERSRISINGANDA 0406682006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDEKENTONANDA 0406442006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDEMOUNTAINANDA 0405372003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDENASKAANDA 0890211987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEHALSEYANDA 0891991986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEHALSEYANDA 0890571986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEAM THERAPANDA 0887981985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEPIONEER PHARMSANDA 0878391984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEDURAMED PHARMS BARRANDA 0882321983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEPLIVAANDA 0882051983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDECHARTWELL RXANDA 0882121983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CYPROHEPTADINE HYDROCHLORIDEMD PHARMANDA 0875661982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEMORTON GROVEANDA 0870011982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEASCOTANDA 0876851982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDERLDACTAVIS MID ATLANTICANDA 086833—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDECHARTWELL RXANDA 086808—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDERLDHERITAGE PHARMAANDA 087056—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEKV PHARMANDA 086737—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEMYLANANDA 086678—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 087129—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDESUPERPHARMANDA 087405—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEVITARINEANDA 087284—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEWATSON LABSANDA 085245—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEWATSON LABSANDA 086165—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CYPROHEPTADINE HYDROCHLORIDEWATSON LABSANDA 086580—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
44 yr 5 mo ago
Most recent approval
4 yr 9 mo ago
Approvals span 1982–2021 across 41 FDA applications.
Brand (NDA) 25%
Generic (ANDA) 3995%
Cyproheptadine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
