Tolmetin Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2015-07-29)
Oldest Current Product
1994-08-30
License(s)
ANDA
RxNORM
ORAL TABLET\TOLMETIN
FDAOB
ORAL\CAPSULE\TOLMETIN SODIUM
ORAL\TABLET\TOLMETIN SODIUM
SPL Active
ORAL\TABLET, FILM COATED\TOLMETIN SODIUM
ORAL\TABLET\TOLMETIN SODIUM
SPL Moiety
ORAL\TABLET, FILM COATED\TOLMETIN
ORAL\TABLET\TOLMETIN

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1534890506ANDAMutual Pharmaceutical Company, Inc.2009-09-04TOLMETIN SODIUMORALTABLETANDA073311a6c72634-4613-4d21-bc9a-09dad17eb137

tolmetin 600 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780313ANDAMylan Pharmaceuticals Inc.1994-08-30TOLMETIN SODIUMORALTABLET, FILM COATEDANDA0744736e0228a8-e3d3-4ae9-8873-d7aa3e0dcfee

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900987ANDAStat Rx Usa Llc2009-11-02TOLMETIN SODIUMORALTABLET, FILM COATED003780313ANDA0744734b4b0091-bcf9-499e-a23e-efcee252f2f6

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA073290TOLMETIN SODIUMTEVA PHARMACEUTICALS USA INC1991-11-27ANDA073290_001Tolmetin Oral Capsule
2ANDA073308TOLMETIN SODIUMTrueACTAVIS ELIZABETH LLC1992-01-24ANDA073308_001Tolmetin Oral Capsule
3ANDA073310TOLMETIN SODIUMMUTUAL PHARMACEUTICAL CO INC1991-11-27ANDA073310_001
4ANDA073311TOLMETIN SODIUMTrueMUTUAL PHARMACEUTICAL CO INC1991-11-27ANDA073311_001Tolmetin Oral Capsule
5ANDA073392TOLMETIN SODIUMTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1992-01-24ANDA073392_001Tolmetin Oral Capsule
6ANDA073393TOLMETIN SODIUMMYLAN PHARMACEUTICALS INC1993-05-27ANDA073393_001Tolmetin Oral Capsule
7ANDA073462TOLMETIN SODIUMTrueSANDOZ INC1992-04-30ANDA073462_001Tolmetin Oral Capsule
8ANDA073519TOLMETIN SODIUMTrueTEVA PHARMACEUTICALS USA INC1992-05-29ANDA073519_001Tolmetin Oral Capsule
9ANDA073527TOLMETIN SODIUMTrueACTAVIS ELIZABETH LLC1992-06-30ANDA073527_001
10ANDA073588TOLMETIN SODIUMTrueSANDOZ INC1992-07-31ANDA073588_001
11ANDA074002TOLMETIN SODIUMTrueSANDOZ INC1993-09-27ANDA074002_001
12ANDA074399TOLMETIN SODIUMTrueG AND W LABORATORIES INC1996-03-28ANDA074399_001
13ANDA074473TOLMETIN SODIUMMYLAN PHARMACEUTICALS INC1994-08-30ANDA074473_001
14ANDA074729TOLMETIN SODIUMTrueG AND W LABORATORIES INC1997-02-27ANDA074729_001
15NDA017628TOLECTINTrueORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA017628_001, NDA017628_002
16NDA018084TOLECTIN DSTrueORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA018084_001Tolmetin Oral Capsule

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
3ANDA073310_001RXTOLMETIN SODIUM (EQ 200MG BASE)ORALTABLETFalseAB1991-11-27TOLMETIN SODIUM
4ANDA073311_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalse1991-11-27TOLMETIN SODIUM
5ANDA073392_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalse1992-01-24TOLMETIN SODIUM
6ANDA073393_001RXTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalseAB1993-05-27TOLMETIN SODIUM
7ANDA073462_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalse1992-04-30TOLMETIN SODIUM
8ANDA073519_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalse1992-05-29TOLMETIN SODIUM
9ANDA073527_001discontinuedTOLMETIN SODIUM (EQ 600MG BASE)ORALTABLETFalse1992-06-30TOLMETIN SODIUM
10ANDA073588_001discontinuedTOLMETIN SODIUM (EQ 200MG BASE)ORALTABLETFalse1992-07-31TOLMETIN SODIUM
11ANDA074002_001discontinuedTOLMETIN SODIUM (EQ 600MG BASE)ORALTABLETFalse1993-09-27TOLMETIN SODIUM
12ANDA074399_001discontinuedTOLMETIN SODIUM (EQ 600MG BASE)ORALTABLETFalse1996-03-28TOLMETIN SODIUM
13ANDA074473_001RXTOLMETIN SODIUM (EQ 600MG BASE)ORALTABLETTrueAB1994-08-30TOLMETIN SODIUM
14ANDA074729_001discontinuedTOLMETIN SODIUM (EQ 600MG BASE)ORALTABLETFalse1997-02-27TOLMETIN SODIUM
15NDA017628_001discontinuedTOLMETIN SODIUM (EQ 200MG BASE)ORALTABLETFalseTOLECTIN
16NDA017628_002discontinuedTOLMETIN SODIUM (EQ 600MG BASE)ORALTABLETFalse1989-03-08TOLECTIN
17NDA018084_001discontinuedTOLMETIN SODIUM (EQ 400MG BASE)ORALCAPSULEFalseTOLECTIN DS

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
14b4b0091-bcf9-499e-a23e-efcee252f2f6 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-08-261165900987
26e0228a8-e3d3-4ae9-8873-d7aa3e0dcfee (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-07-295003780313
3a6c72634-4613-4d21-bc9a-09dad17eb137 (view SPL)TOLMETIN SODIUM CAPSULES USP TOLMETIN SODIUM TABLETS USPprescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2015-02-235534890506, 534890507Tolmetin Oral Capsule

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