FDA Orange Book · active-ingredient family
Meprobamate
Meprobamate: 19 brands, 38 generics; first approved Mar 18, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 38 ANDA applications approved.
Brands (NDA)
19
Generics (ANDA)
38
Listed patents
0
Presentations
77
Brand (NDA) products
Originator applications
- MILTOWNRLDMEDPOINTE PHARM HLCNDA 009698—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - MEDPOINTE PHARM HLCNDA 011284—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 400MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - WYETH AYERSTNDA 012455—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG CAPSULE ORAL Discontinued — - WYETH AYERSTNDA 010028—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - TEVANDA 016069—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATECHARTWELL MOLECULARNDA 014882—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - MEPROBAMATEELKINS SINNNDA 015426—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - MEPROBAMATEHEATHERNDA 016928—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEIMPAX LABSNDA 014322—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - MEPROBAMATEIVAX SUB TEVA PHARMSNDA 015438—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - MEPROBAMATEMALLARDNDA 015072—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEMK LABSNDA 014368—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - MEPROBAMATEPVT FORMNDA 014601—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATESANDOZNDA 014547—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - MEPROBAMATESTANLABS PHARMNDA 014474—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - MEPROBAMATEVALEANT PHARM INTLNDA 015139—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - MEPROBAMATEWEST WARDNDA 015417—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - HALSEYNDA 014359—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - SOLVAYNDA 016249—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued —
Generic (ANDA) products (38)
Abbreviated applications
- MEPROBAMATETAROANDA 20099820112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - MEPROBAMATERSALEMBIC PHARMS LTDANDA 09012220092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AA 400MG TABLET ORAL Rx AA - MEPROBAMATEINVAGEN PHARMSANDA 04079720082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AA 400MG TABLET ORAL Rx AA - MEPROBAMATELEE KMANDA 0895381987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEVANGARDANDA 0880111982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEUSL PHARMAANDA 0878251982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - MEPROBAMATEUSL PHARMAANDA 0878261982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - FERNDALE LABSANDA 084030—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - ALRAANDA 080380—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - MEPROBAMATEACELLAANDA 084153—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEBARRANDA 084230—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - MEPROBAMATEHEATHERANDA 084329—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - MEPROBAMATEIVAX SUB TEVA PHARMSANDA 084181—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - MEPROBAMATELEDERLEANDA 086299—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEMYLANANDA 083618—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATENEXGEN PHARMA INCANDA 084220—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - MEPROBAMATENEXGEN PHARMA INCANDA 084589—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEPARKE DAVISANDA 084744—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - MEPROBAMATEPERRIGOANDA 084546—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - MEPROBAMATEPERRIGOANDA 084547—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEPHARMAVITEANDA 084438—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEPUREPAC PHARMANDA 084804—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - MEPROBAMATERISINGANDA 080655—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEROXANEANDA 084332—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - MEPROBAMATESCHERER LABSANDA 083343—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATESOLVAYANDA 084435—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - MEPROBAMATESUN PHARM INDUSTRIESANDA 080699—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - MEPROBAMATETABLICAPSANDA 083494—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATERLDWATSON LABSANDA 083304—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - MEPROBAMATEWATSON LABSANDA 085720—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - MEPROBAMATERLDWATSON LABSANDA 083308—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEWATSON LABSANDA 085721—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEPROBAMATEWATSON LABSANDA 084274—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - MEPROBAMATEWATSON LABSANDA 085719—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - MEPROBAMATEWHITEWORTH TOWN PLSNANDA 083830—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - MEPROBAMATEWHITEWORTH TOWN PLSNANDA 083442—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - MEDPOINTE PHARM HLCANDA 083919—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - SOLVAYANDA 084369—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG 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 3 mo ago
Most recent approval
15 yr 7 mo ago
Approvals span 1982–2011 across 57 FDA applications.
Brand (NDA) 1933%
Generic (ANDA) 3867%
Meprobamate: 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
