FDA Orange Book · active-ingredient family
Carisoprodol
Carisoprodol: 2 brands, 24 generics; first approved Apr 20, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 24 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
24
Listed patents
0
Presentations
32
Brand (NDA) products
Originator applications
- SOMARLDMYLAN SPECIALITY LPNDA 011792—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA 250MG CAPSULE ORAL Discontinued — 250MG TABLET ORAL Rx AB - SCHERINGNDA 012155—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Discontinued —
Generic (ANDA) products (24)
Abbreviated applications
- CARISOPRODOLPOINTVIEW HLDINGSANDA 2117892021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA - CARISOPRODOLMPP PHARMAANDA 20723720172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 350MG TABLET ORAL Rx AA - CARISOPRODOLAUROBINDO PHARMAANDA 04079220162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA 250MG TABLET ORAL Rx AB - CARISOPRODOLSTRIDES PHARMAANDA 20551320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 350MG TABLET ORAL Discontinued — - CARISOPRODOLHERITAGEANDA 20512620152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 350MG TABLET ORAL Rx AA - CARISOPRODOLNATCOANDA 0909882014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA - CARISOPRODOLORIENT PHARMA CO LTDANDA 2050852014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA - CARISOPRODOLSCIEGEN PHARMSANDA 2033742014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA - CARISOPRODOLINGENUS PHARMS LLCANDA 0408232008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA - CARISOPRODOLSUN PHARM INDS LTDANDA 0407552007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Discontinued — - CARISOPRODOLACCELRX LABSANDA 0405762005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA - CARISOPRODOLABLEANDA 0404212001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Discontinued — - CARISOPRODOLEPIC PHARMA LLCANDA 0403972000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Discontinued — - CARISOPRODOLCHARTWELL RXANDA 0402451997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA - CARISOPRODOLOXFORD PHARMSANDA 0401881997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA - CARISOPRODOLWATSON LABSANDA 0401521996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Discontinued — - CARISOPRODOLHIKMA INTL PHARMSANDA 0401241996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Discontinued — - CARISOPRODOLSUN PHARM INDUSTRIESANDA 0893461991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Discontinued — - CARISOPRODOLSENORES PHARMSANDA 0810251989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA - CARISOPRODOLPIONEER PHARMSANDA 0893901988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Discontinued — - CARISOPRODOLSANDOZANDA 0895661988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Discontinued — - CARISOPRODOLWATSON LABSANDA 0874991982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Rx AA - CARISOPRODOLWATSON LABSANDA 085433—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG TABLET ORAL Discontinued — - CARISOPRODOLWATSON LABS TEVAANDA 086179—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG 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
45 yr ago
Most recent approval
4 yr 11 mo ago
Approvals span 1982–2021 across 26 FDA applications.
Brand (NDA) 28%
Generic (ANDA) 2492%
Carisoprodol: 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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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
