Assyro AI

FDA Orange Book · active-ingredient family

Meprobamate

Meprobamate is approved as 19 brand and 38 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MILTOWN · NDA 009698

19

Brand (NDA)

38

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, capsule, extended release, tablet

ProductApplicantApplicationTEApproved
MILTOWNRLD×2MEDPOINTE PHARM HLCNDA 009698—Approved Prior to Jan 1, 1982
MEPROSPAN×2MEDPOINTE PHARM HLCNDA 011284—Approved Prior to Jan 1, 1982
EQUANILWYETH AYERSTNDA 012455—Approved Prior to Jan 1, 1982
EQUANIL×2WYETH AYERSTNDA 010028—Approved Prior to Jan 1, 1982
MEPRIAMTEVANDA 016069—Approved Prior to Jan 1, 1982
MEPROBAMATE×2CHARTWELL MOLECULARNDA 014882—Approved Prior to Jan 1, 1982
MEPROBAMATE×2ELKINS SINNNDA 015426—Approved Prior to Jan 1, 1982
MEPROBAMATEHEATHERNDA 016928—Approved Prior to Jan 1, 1982
MEPROBAMATE×2IMPAX LABSNDA 014322—Approved Prior to Jan 1, 1982
MEPROBAMATE×2IVAX SUB TEVA PHARMSNDA 015438—Approved Prior to Jan 1, 1982
MEPROBAMATEMALLARDNDA 015072—Approved Prior to Jan 1, 1982
MEPROBAMATE×2MK LABSNDA 014368—Approved Prior to Jan 1, 1982
MEPROBAMATEPVT FORMNDA 014601—Approved Prior to Jan 1, 1982
MEPROBAMATE×2SANDOZNDA 014547—Approved Prior to Jan 1, 1982
MEPROBAMATE×2STANLABS PHARMNDA 014474—Approved Prior to Jan 1, 1982
MEPROBAMATE×2VALEANT PHARM INTLNDA 015139—Approved Prior to Jan 1, 1982
MEPROBAMATE×2WEST WARDNDA 015417—Approved Prior to Jan 1, 1982
NEURAMATE×2HALSEYNDA 014359—Approved Prior to Jan 1, 1982
TRANMEPSOLVAYNDA 016249—Approved Prior to Jan 1, 1982

Generic (ANDA) products (38)

ProductApplicantApplicationTEApproved
MEPROBAMATE×2TAROANDA 200998—May 23, 2011
MEPROBAMATE×2ALEMBIC PHARMS LTDANDA 090122AAFeb 18, 2009
MEPROBAMATE×2INVAGEN PHARMSANDA 040797AAFeb 27, 2008
MEPROBAMATELEE KMANDA 089538—Nov 25, 1987
MEPROBAMATEVANGARDANDA 088011—Jul 14, 1982
MEPROBAMATEUSL PHARMAANDA 087825—Mar 18, 1982
MEPROBAMATEUSL PHARMAANDA 087826—Mar 18, 1982
AMOSENEFERNDALE LABSANDA 084030—Approved Prior to Jan 1, 1982
BAMATE×2ALRAANDA 080380—Approved Prior to Jan 1, 1982
MEPROBAMATEACELLAANDA 084153—Approved Prior to Jan 1, 1982
MEPROBAMATEBARRANDA 084230—Approved Prior to Jan 1, 1982
MEPROBAMATEHEATHERANDA 084329—Approved Prior to Jan 1, 1982
MEPROBAMATEIVAX SUB TEVA PHARMSANDA 084181—Approved Prior to Jan 1, 1982
MEPROBAMATELEDERLEANDA 086299—Approved Prior to Jan 1, 1982
MEPROBAMATEMYLANANDA 083618—Approved Prior to Jan 1, 1982
MEPROBAMATENEXGEN PHARMA INCANDA 084220—Approved Prior to Jan 1, 1982
MEPROBAMATENEXGEN PHARMA INCANDA 084589—Approved Prior to Jan 1, 1982
MEPROBAMATE×2PARKE DAVISANDA 084744—Approved Prior to Jan 1, 1982
MEPROBAMATEPERRIGOANDA 084546—Approved Prior to Jan 1, 1982
MEPROBAMATEPERRIGOANDA 084547—Approved Prior to Jan 1, 1982
MEPROBAMATEPHARMAVITEANDA 084438—Approved Prior to Jan 1, 1982
MEPROBAMATE×2PUREPAC PHARMANDA 084804—Approved Prior to Jan 1, 1982
MEPROBAMATERISINGANDA 080655—Approved Prior to Jan 1, 1982
MEPROBAMATEROXANEANDA 084332—Approved Prior to Jan 1, 1982
MEPROBAMATESCHERER LABSANDA 083343—Approved Prior to Jan 1, 1982
MEPROBAMATESOLVAYANDA 084435—Approved Prior to Jan 1, 1982
MEPROBAMATE×2SUN PHARM INDUSTRIESANDA 080699—Approved Prior to Jan 1, 1982
MEPROBAMATETABLICAPSANDA 083494—Approved Prior to Jan 1, 1982
MEPROBAMATERLDWATSON LABSANDA 083304—Approved Prior to Jan 1, 1982
MEPROBAMATEWATSON LABSANDA 085720—Approved Prior to Jan 1, 1982
MEPROBAMATERLDWATSON LABSANDA 083308—Approved Prior to Jan 1, 1982
MEPROBAMATEWATSON LABSANDA 085721—Approved Prior to Jan 1, 1982
MEPROBAMATEWATSON LABSANDA 084274—Approved Prior to Jan 1, 1982
MEPROBAMATEWATSON LABSANDA 085719—Approved Prior to Jan 1, 1982
MEPROBAMATEWHITEWORTH TOWN PLSNANDA 083830—Approved Prior to Jan 1, 1982
MEPROBAMATEWHITEWORTH TOWN PLSNANDA 083442—Approved Prior to Jan 1, 1982
MILTOWNMEDPOINTE PHARM HLCANDA 083919—Approved Prior to Jan 1, 1982
TRANMEPSOLVAYANDA 084369—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.

Meprobamate — frequently asked questions

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

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