Tolmetin Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-08-05)
Oldest Current Product
1993-05-27
License(s)
ANDA
RxNORM
ORAL CAPSULE\TOLMETIN
FDAOB
ORAL\CAPSULE\TOLMETIN SODIUM
SPL Active
ORAL\CAPSULE\TOLMETIN SODIUM
SPL Moiety
ORAL\CAPSULE\TOLMETIN

product(s) by strength(s)

tolmetin 400 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932075ANDATeva Pharmaceuticals Usa Inc2012-07-26TOLMETIN SODIUMORALCAPSULEANDA073290332731f4-6625-4b6c-9d8f-36e8a11d2d0d
2003785200ANDAMylan Pharmaceuticals Inc.1993-05-27TOLMETIN SODIUMORALCAPSULEANDA073393dbae03d7-b6ab-4139-8e79-29c05924849e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1534890507ANDAMutual Pharmaceutical Company, Inc.2009-09-04TOLMETIN SODIUMORALCAPSULEANDA073311a6c72634-4613-4d21-bc9a-09dad17eb137

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA073290TOLMETIN SODIUMTEVA PHARMACEUTICALS USA INC1991-11-27ANDA073290_001Tolmetin Oral Tablet
2ANDA073308TOLMETIN SODIUMTrueACTAVIS ELIZABETH LLC1992-01-24ANDA073308_001Tolmetin Oral Tablet
3ANDA073311TOLMETIN SODIUMTrueMUTUAL PHARMACEUTICAL CO INC1991-11-27ANDA073311_001Tolmetin Oral Tablet
4ANDA073392TOLMETIN SODIUMTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1992-01-24ANDA073392_001Tolmetin Oral Tablet
5ANDA073393TOLMETIN SODIUMMYLAN PHARMACEUTICALS INC1993-05-27ANDA073393_001Tolmetin Oral Tablet
6ANDA073462TOLMETIN SODIUMTrueSANDOZ INC1992-04-30ANDA073462_001Tolmetin Oral Tablet
7ANDA073519TOLMETIN SODIUMTrueTEVA PHARMACEUTICALS USA INC1992-05-29ANDA073519_001Tolmetin Oral Tablet
8NDA018084TOLECTIN DSTrueORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA018084_001Tolmetin Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073290_001RXTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULETrueAB1991-11-27TOLMETIN SODIUM
2ANDA073308_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalse1992-01-24TOLMETIN SODIUM
3ANDA073311_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalse1991-11-27TOLMETIN SODIUM
4ANDA073392_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalse1992-01-24TOLMETIN SODIUM
5ANDA073393_001RXTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalseAB1993-05-27TOLMETIN SODIUM
6ANDA073462_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalse1992-04-30TOLMETIN SODIUM
7ANDA073519_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalse1992-05-29TOLMETIN SODIUM
8NDA018084_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalseTOLECTIN DS

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
1332731f4-6625-4b6c-9d8f-36e8a11d2d0d (view SPL)TOLMETIN SODIUM CAPSULES USP 2075 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-054000932075
2a6c72634-4613-4d21-bc9a-09dad17eb137 (view SPL)TOLMETIN SODIUM CAPSULES USP TOLMETIN SODIUM TABLETS USPprescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2015-02-235534890507, 534890506Tolmetin Oral Tablet
3dbae03d7-b6ab-4139-8e79-29c05924849e (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-07-286003785200

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