FDA — authorised 28 April 1955
- Application: NDA009698
- Marketing authorisation holder: MEDPOINTE PHARM HLC
- Local brand name: MILTOWN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 MEPROBAMATE in United States
FDA authorised MEPROBAMATE on 28 April 1955
Marketing authorisations
FDA — authorised 26 July 1955
- Application: NDA010028
- Marketing authorisation holder: WYETH AYERST
- Local brand name: EQUANIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 1963
- Application: NDA014547
- Marketing authorisation holder: SANDOZ
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 1964
- Application: NDA015072
- Marketing authorisation holder: MALLARD
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 December 1964
- Application: NDA015417
- Marketing authorisation holder: WEST WARD
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 1967
- Application: NDA016249
- Marketing authorisation holder: SOLVAY
- Local brand name: TRANMEP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 1972
- Application: ANDA080655
- Marketing authorisation holder: RISING
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 1972
- Application: ANDA080699
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 May 1973
- Application: ANDA083308
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 1973
- Application: ANDA083442
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1974
- Application: ANDA083830
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 1974
- Application: ANDA084181
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 1974
- Application: ANDA084030
- Marketing authorisation holder: FERNDALE LABS
- Local brand name: AMOSENE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 July 1974
- Application: ANDA084153
- Marketing authorisation holder: ACELLA
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 July 1974
- Application: ANDA084230
- Marketing authorisation holder: BARR
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1974
- Application: ANDA084220
- Marketing authorisation holder: NEXGEN PHARMA INC
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 February 1975
- Application: NDA014601
- Marketing authorisation holder: PVT FORM
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 1975
- Application: ANDA084589
- Marketing authorisation holder: NEXGEN PHARMA INC
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 December 1975
- Application: ANDA084744
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 November 1976
- Application: ANDA084274
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 January 1977
- Application: NDA014474
- Marketing authorisation holder: STANLABS PHARM
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1977
- Application: ANDA085719
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1977
- Application: ANDA085720
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1977
- Application: ANDA085721
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 1982
- Application: ANDA088011
- Marketing authorisation holder: VANGARD
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 January 1983
- Application: ANDA084546
- Marketing authorisation holder: PERRIGO
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 1983
- Application: ANDA084547
- Marketing authorisation holder: PERRIGO
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2008
- Application: ANDA040797
- Marketing authorisation holder: INVAGEN PHARMS
- Status: approved
FDA — authorised 18 February 2009
- Application: ANDA090122
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 2011
- Application: ANDA200998
- Marketing authorisation holder: TARO
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA016069
- Marketing authorisation holder: TEVA
- Local brand name: MEPRIAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA014322
- Marketing authorisation holder: IMPAX LABS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA015139
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083343
- Marketing authorisation holder: SCHERER LABS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084369
- Marketing authorisation holder: SOLVAY
- Local brand name: TRANMEP
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA011284
- Marketing authorisation holder: MEDPOINTE PHARM HLC
- Local brand name: MEPROSPAN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: NDA012455
- Marketing authorisation holder: WYETH AYERST
- Local brand name: EQUANIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA016928
- Marketing authorisation holder: HEATHER
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084332
- Marketing authorisation holder: ROXANE
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084329
- Marketing authorisation holder: HEATHER
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA084804
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA015426
- Marketing authorisation holder: ELKINS SINN
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083494
- Marketing authorisation holder: TABLICAPS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA015438
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083618
- Marketing authorisation holder: MYLAN
- Local brand name: MEPROBAMATE
- Indication: TABLET — ORAL
- Status: approved
MEPROBAMATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is MEPROBAMATE approved in United States?
Yes. FDA authorised it on 28 April 1955; FDA authorised it on 26 July 1955; FDA authorised it on 26 July 1963.
Who is the marketing authorisation holder for MEPROBAMATE in United States?
MEDPOINTE PHARM HLC holds the US marketing authorisation.