Meprobamate Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alembic Limited (2013-07-23)
Oldest Current Product
1973-04-23
License(s)
ANDA
RxNORM
ORAL TABLET\MEPROBAMATE
FDAOB
ORAL\TABLET\MEPROBAMATE
SPL Active
ORAL\TABLET\MEPROBAMATE
SPL Moiety
ORAL\TABLET\MEPROBAMATE

product(s) by strength(s)

meprobamate 200 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005915239ANDAWatson Laboratories, Inc.1973-04-23MEPROBAMATEORALTABLETANDA083304a27d7877-38e4-4437-afd3-3d570c0dead1
2231550128ANDAHeritage Pharmaceuticals Inc.2009-05-01MEPROBAMATEORALTABLETANDA090122223068d2-e7cc-4f15-8be3-30263ea5cbab
3467080019ANDAAlembic Limited2013-07-23MEPROBAMATEORALTABLETANDA090122a0891a32-105b-48bc-a246-5e179d2e7fa1

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724147ANDATaro Pharmaceuticals U.S.A., Inc.2011-05-23MEPROBAMATEORALTABLETANDA2009984a9ad4f6-6826-4cb8-a097-2d2ea2c91d8b
2525494147ANDATaro Pharmaceutical Industries Ltd.2011-05-23MEPROBAMATEORALTABLETANDA200998e9aa3d4c-f2e9-4ca9-b563-85fac4024539

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551110640ANDADr. Reddy'S Laboratories Ltd2008-01-03MEPROBAMATEORALTABLET677870261ANDA040797d6fa7f20-5125-ff79-4e8d-00542a13472a

meprobamate 400 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005915238ANDAWatson Laboratories, Inc.1973-05-03MEPROBAMATEORALTABLETANDA083308a27d7877-38e4-4437-afd3-3d570c0dead1
2231550129ANDAHeritage Pharmaceuticals Inc.2009-05-01MEPROBAMATEORALTABLETANDA090122223068d2-e7cc-4f15-8be3-30263ea5cbab
3467080020ANDAAlembic Limited2013-07-23MEPROBAMATEORALTABLETANDA090122a0891a32-105b-48bc-a246-5e179d2e7fa1

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724148ANDATaro Pharmaceuticals U.S.A., Inc.2011-05-23MEPROBAMATEORALTABLETANDA2009984a9ad4f6-6826-4cb8-a097-2d2ea2c91d8b
2525494148ANDATaro Pharmaceutical Industries Ltd.2011-05-23MEPROBAMATEORALTABLETANDA200998e9aa3d4c-f2e9-4ca9-b563-85fac4024539

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551110641ANDADr. Reddy'S Laboratories Ltd2008-01-03MEPROBAMATEORALTABLET677870262ANDA040797d6fa7f20-5125-ff79-4e8d-00542a13472a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040797MEPROBAMATEINVAGEN PHARMACEUTICALS INC2008-02-27ANDA040797_001, ANDA040797_002
2ANDA080380BAMATETrueALRA LABORATORIES INCANDA080380_001, ANDA080380_002
3ANDA080655MEPROBAMATETrueSANDOZ INCANDA080655_001
4ANDA080699MEPROBAMATETrueMUTUAL PHARMACEUTICAL CO INCANDA080699_001, ANDA080699_002
5ANDA083304MEPROBAMATEWATSON LABORATORIES INCANDA083304_001
6ANDA083308MEPROBAMATEWATSON LABORATORIES INCANDA083308_001
7ANDA083343MEPROBAMATETrueSCHERER LABORATORIES INCANDA083343_001
8ANDA083442MEPROBAMATETrueWHITEWORTH TOWNE PAULSEN INCANDA083442_001
9ANDA083494MEPROBAMATETrueTABLICAPS INCANDA083494_001
10ANDA083618MEPROBAMATETrueMYLAN PHARMACEUTICALS INCANDA083618_001
11ANDA083830MEPROBAMATETrueWHITEWORTH TOWNE PAULSEN INCANDA083830_001
12ANDA083919MILTOWNTrueMEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INCANDA083919_001
13ANDA084030AMOSENETrueFERNDALE LABORATORIES INCANDA084030_001
14ANDA084153MEPROBAMATETrueIVC INDUSTRIES INC DBA INVERNESS MEDICAL NUTRITIONALS GROUPANDA084153_001
15ANDA084181MEPROBAMATETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA084181_001
16ANDA084220MEPROBAMATETrueNEXGEN PHARMA INCANDA084220_001
17ANDA084230MEPROBAMATETrueBARR LABORATORIES INCANDA084230_001
18ANDA084274MEPROBAMATETrueWATSON LABORATORIES INCANDA084274_001
19ANDA084329MEPROBAMATETrueHEATHER DRUG CO INCANDA084329_001
20ANDA084332MEPROBAMATETrueROXANE LABORATORIES INCANDA084332_001
21ANDA084369TRANMEPTrueSOLVAY PHARMACEUTICALSANDA084369_001
22ANDA084435MEPROBAMATETrueSOLVAY PHARMACEUTICALSANDA084435_001
23ANDA084438MEPROBAMATETruePHARMAVITE PHARMACEUTICALSANDA084438_001
24ANDA084546MEPROBAMATETrueL PERRIGO COANDA084546_001
25ANDA084547MEPROBAMATETrueL PERRIGO COANDA084547_001
26ANDA084589MEPROBAMATETrueNEXGEN PHARMA INCANDA084589_001
27ANDA084744MEPROBAMATETruePARKE DAVIS DIV WARNER LAMBERT COANDA084744_001, ANDA084744_002
28ANDA084804MEPROBAMATETruePUREPAC PHARMACEUTICAL COANDA084804_001, ANDA084804_002
29ANDA085719MEPROBAMATETrueWATSON LABORATORIES INCANDA085719_001
30ANDA085720MEPROBAMATETrueWATSON LABORATORIES INCANDA085720_001
31ANDA085721MEPROBAMATETrueWATSON LABORATORIES INCANDA085721_001
32ANDA086299MEPROBAMATETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA086299_001
33ANDA087825MEPROBAMATETrueUSL PHARMA INC1982-03-18ANDA087825_001
34ANDA087826MEPROBAMATETrueUSL PHARMA INC1982-03-18ANDA087826_001
35ANDA088011MEPROBAMATETrueVANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO1982-07-14ANDA088011_001
36ANDA089538MEPROBAMATETrueKM LEE LABORATORIES INC1987-11-25ANDA089538_001
37ANDA090122MEPROBAMATEALEMBIC PHARMACEUTICALS LTD2009-02-18ANDA090122_001, ANDA090122_002
38ANDA200998MEPROBAMATETrueTARO PHARMACEUTICAL INDUSTRIES LTD2011-05-23ANDA200998_001, ANDA200998_002
39NDA009698MILTOWNTrueMEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INCNDA009698_002, NDA009698_004
40NDA010028EQUANILTrueWYETH AYERST LABORATORIESNDA010028_004, NDA010028_005
41NDA014322MEPROBAMATETrueIMPAX LABORATORIES INCNDA014322_001, NDA014322_002
42NDA014359NEURAMATETrueHALSEY DRUG CO INCNDA014359_001, NDA014359_002
43NDA014368MEPROBAMATETrueMK LABORATORIES INCNDA014368_002, NDA014368_004
44NDA014474MEPROBAMATETrueSTANLABS PHARMACEUTICAL CO SUB SIMPAK CORPNDA014474_002, NDA014474_004
45NDA014547MEPROBAMATETrueSANDOZ INCNDA014547_001, NDA014547_002
46NDA014601MEPROBAMATETruePRIVATE FORMULATIONS INCNDA014601_001
47NDA014882MEPROBAMATETrueLANNETT CO INCNDA014882_001, NDA014882_002
48NDA015072MEPROBAMATETrueMALLARD INCNDA015072_002
49NDA015139MEPROBAMATETrueVALEANT PHARMACEUTICALS INTERNATIONALNDA015139_005, NDA015139_006
50NDA015417MEPROBAMATETrueWEST WARD PHARMACEUTICAL CORPNDA015417_002, NDA015417_003
51NDA015426MEPROBAMATETrueELKINS SINN DIV AH ROBINS CO INCNDA015426_001, NDA015426_002
52NDA015438MEPROBAMATETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USANDA015438_001, NDA015438_002
53NDA016069MEPRIAMTrueTEVA PHARMACEUTICALS USA INCNDA016069_001
54NDA016249TRANMEPTrueSOLVAY PHARMACEUTICALSNDA016249_001
55NDA016928MEPROBAMATETrueHEATHER DRUG CO INCNDA016928_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040797_001RXMEPROBAMATE (200MG)ORALTABLETFalseAA2008-02-27MEPROBAMATE
2ANDA040797_002RXMEPROBAMATE (400MG)ORALTABLETFalseAA2008-02-27MEPROBAMATE
3ANDA080380_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalseBAMATE
4ANDA080380_002discontinuedMEPROBAMATE (400MG)ORALTABLETFalseBAMATE
5ANDA080655_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
6ANDA080699_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
7ANDA080699_002discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
8ANDA083304_001RXMEPROBAMATE (200MG)ORALTABLETTrueAAMEPROBAMATE
9ANDA083308_001RXMEPROBAMATE (400MG)ORALTABLETTrueAAMEPROBAMATE
10ANDA083343_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
11ANDA083442_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
12ANDA083494_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
13ANDA083618_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
14ANDA083830_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
15ANDA083919_001discontinuedMEPROBAMATE (600MG)ORALTABLETFalseMILTOWN
16ANDA084030_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseAMOSENE
17ANDA084153_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
18ANDA084181_001discontinuedMEPROBAMATE (600MG)ORALTABLETFalseMEPROBAMATE
19ANDA084220_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
20ANDA084230_001discontinuedMEPROBAMATE (600MG)ORALTABLETFalseMEPROBAMATE
21ANDA084274_001discontinuedMEPROBAMATE (600MG)ORALTABLETFalseMEPROBAMATE
22ANDA084329_001discontinuedMEPROBAMATE (600MG)ORALTABLETFalseMEPROBAMATE
23ANDA084332_001discontinuedMEPROBAMATE (600MG)ORALTABLETFalseMEPROBAMATE
24ANDA084369_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseTRANMEP
25ANDA084435_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
26ANDA084438_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
27ANDA084546_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
28ANDA084547_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
29ANDA084589_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
30ANDA084744_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
31ANDA084744_002discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
32ANDA084804_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
33ANDA084804_002discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
34ANDA085719_001discontinuedMEPROBAMATE (600MG)ORALTABLETFalseMEPROBAMATE
35ANDA085720_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
36ANDA085721_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
37ANDA086299_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
38ANDA087825_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalse1982-03-18MEPROBAMATE
39ANDA087826_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalse1982-03-18MEPROBAMATE
40ANDA088011_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalse1982-07-14MEPROBAMATE
41ANDA089538_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalse1987-11-25MEPROBAMATE
42ANDA090122_001RXMEPROBAMATE (200MG)ORALTABLETFalseAA2009-02-18MEPROBAMATE
43ANDA090122_002RXMEPROBAMATE (400MG)ORALTABLETFalseAA2009-02-18MEPROBAMATE
44ANDA200998_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalse2011-05-23MEPROBAMATE
45ANDA200998_002discontinuedMEPROBAMATE (400MG)ORALTABLETFalse2011-05-23MEPROBAMATE
46NDA009698_002discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMILTOWN
47NDA009698_004discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMILTOWN
48NDA010028_004discontinuedMEPROBAMATE (400MG)ORALTABLETFalseEQUANIL
49NDA010028_005discontinuedMEPROBAMATE (200MG)ORALTABLETFalseEQUANIL
50NDA014322_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
51NDA014322_002discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
52NDA014359_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseNEURAMATE
53NDA014359_002discontinuedMEPROBAMATE (200MG)ORALTABLETFalseNEURAMATE
54NDA014368_002discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
55NDA014368_004discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
56NDA014474_002discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
57NDA014474_004discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
58NDA014547_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
59NDA014547_002discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
60NDA014601_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
61NDA014882_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
62NDA014882_002discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
63NDA015072_002discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
64NDA015139_005discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
65NDA015139_006discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
66NDA015417_002discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
67NDA015417_003discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
68NDA015426_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
69NDA015426_002discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
70NDA015438_001discontinuedMEPROBAMATE (200MG)ORALTABLETFalseMEPROBAMATE
71NDA015438_002discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE
72NDA016069_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPRIAM
73NDA016249_001discontinuedMEPROBAMATE (400MG)ORALTABLETFalseTRANMEP
74NDA016928_003discontinuedMEPROBAMATE (400MG)ORALTABLETFalseMEPROBAMATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1223068d2-e7cc-4f15-8be3-30263ea5cbab (view SPL)Meprobamate Tablets USP Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2013-08-149231550128, 231550129
24a9ad4f6-6826-4cb8-a097-2d2ea2c91d8b (view SPL)Meprobamate Tablets USP CIVprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2011-07-153516724147, 516724148
3a0891a32-105b-48bc-a246-5e179d2e7fa1 (view SPL)Meprobamate Tablets USP Rx OnlyprescriptionHuman PrescriptionAlembic LimitedMANUFACTURE2013-07-231467080019, 467080020
4a27d7877-38e4-4437-afd3-3d570c0dead1 (view SPL)Meprobamate Tablets USP Revised: June 2008 Rx only C-IVprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-06-266005915238, 005915239
5d6fa7f20-5125-ff79-4e8d-00542a13472a (view SPL)Meprobamate TabletsprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2009-09-091551110640, 551110641
6e9aa3d4c-f2e9-4ca9-b563-85fac4024539 (view SPL)Meprobamate Tablets USPprescriptionHuman PrescriptionTaro Pharmaceutical Industries Ltd.MANUFACTURE2011-07-191525494147, 525494148

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII