Aspirin / Carisoprodol / Codeine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mirror Pharmaceuticals Llc (2012-08-16)
Oldest Current Product
1996-04-16
License(s)
ANDA
RxNORM
ORAL TABLET\ASPIRIN:CARISOPRODOL:CODEINE
FDAOB
ORAL\TABLET\ASPIRIN: CARISOPRODOL
ORAL\TABLET\ASPIRIN: CARISOPRODOL: CODEINE PHOSPHATE
SPL Active
ORAL\TABLET\ASPIRIN: CARISOPRODOL: CODEINE PHOSPHATE
SPL Moiety
ORAL\TABLET\ASPIRIN: CARISOPRODOL: CODEINE ANHYDROUS

product(s) by strength(s)

aspirin 325 mg / carisoprodol 200 mg / codeine phosphate 16 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850749ANDAEon Labs, Inc.1996-04-16ASPIRIN, CARISOPRODOL, CODEINE PHOSPHATEORALTABLETANDA040118dcae7a8a-9d9e-4f7f-954c-39e371f30f75
2526820024ANDAMirror Pharmaceuticals Llc2011-06-26ASPIRIN, CARISOPRODOL, CODEINE PHOSPHATEORALTABLETANDA04083205562553-0781-4204-b458-8302c6ee27b1

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1649800176ANDARising Pharmaceuticals, Inc.2010-01-10ASPIRIN, CARISOPRODOL, CODEINE PHOSPHATEORALTABLETANDA04086024364e3a-a4a0-4d1f-90d8-6884c102696d

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040116CARISOPRODOL AND ASPIRINSANDOZ INC1996-04-25ANDA040116_001Aspirin / Carisoprodol Oral Tablet
2ANDA040118CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATESANDOZ INC1996-04-16ANDA040118_001
3ANDA040252CARISOPRODOL AND ASPIRINPROSAM LABS LLC1997-12-10ANDA040252_001Aspirin / Carisoprodol Oral Tablet
4ANDA040283CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATETruePROSAM LABS LLC1998-12-29ANDA040283_001
5ANDA040832CARISOPRODOL AND ASPIRINMIRROR PHARMACEUTICALS LLC2010-01-07ANDA040832_001Aspirin / Carisoprodol Oral Tablet
6ANDA040860CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATETrueMIRROR PHARMACEUTICALS LLC2010-01-07ANDA040860_001
7ANDA088809CARISOPRODOL COMPOUNDTrueWATSON LABORATORIES INC1985-10-03ANDA088809_001Aspirin / Carisoprodol Oral Tablet
8ANDA089594CARISOPRODOL AND ASPIRINHERITAGE PHARMACEUTICALS INC1989-03-31ANDA089594_001Aspirin / Carisoprodol Oral Tablet
9NDA012365SOMA COMPOUNDMEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC1983-07-11NDA012365_005Aspirin / Carisoprodol Oral Tablet
10NDA012366SOMA COMPOUND W/ CODEINEMEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC1983-07-11NDA012366_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040116_001RXASPIRIN (325MG), CARISOPRODOL (200MG)ORALTABLETFalseAB1996-04-25CARISOPRODOL AND ASPIRIN
2ANDA040118_001RXASPIRIN (325MG), CODEINE PHOSPHATE (16MG), CARISOPRODOL (200MG)ORALTABLETFalseAB1996-04-16CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
3ANDA040252_001RXASPIRIN (325MG), CARISOPRODOL (200MG)ORALTABLETFalseAB1997-12-10CARISOPRODOL AND ASPIRIN
4ANDA040283_001discontinuedCARISOPRODOL (200MG), CODEINE PHOSPHATE (16MG), ASPIRIN (325MG)ORALTABLETFalse1998-12-29CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
5ANDA040832_001RXASPIRIN (325MG), CARISOPRODOL (200MG)ORALTABLETFalseAB2010-01-07CARISOPRODOL AND ASPIRIN
6ANDA040860_001discontinuedCODEINE PHOSPHATE (16MG), ASPIRIN (325MG), CARISOPRODOL (200MG)ORALTABLETFalse2010-01-07CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
7ANDA088809_001discontinuedCARISOPRODOL (200MG), ASPIRIN (325MG)ORALTABLETFalse1985-10-03CARISOPRODOL COMPOUND
8ANDA089594_001RXASPIRIN (325MG), CARISOPRODOL (200MG)ORALTABLETFalseAB1989-03-31CARISOPRODOL AND ASPIRIN
9NDA012365_005RXCARISOPRODOL (200MG), ASPIRIN (325MG)ORALTABLETTrueAB1983-07-11SOMA COMPOUND
10NDA012366_002RXCODEINE PHOSPHATE (16MG), ASPIRIN (325MG), CARISOPRODOL (200MG)ORALTABLETTrueAB1983-07-11SOMA COMPOUND W/ CODEINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
105562553-0781-4204-b458-8302c6ee27b1 (view SPL)CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE Tablets, USP200mg/325mg/16mgRx OnlyprescriptionHuman PrescriptionMirror Pharmaceuticals Llcmanufacture2012-08-162526820024
224364e3a-a4a0-4d1f-90d8-6884c102696d (view SPL)CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE TABLETS, USP 200 mg/325 mg/16 mgprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.MANUFACTURE2012-08-233649800176
3dcae7a8a-9d9e-4f7f-954c-39e371f30f75 (view SPL)Carisoprodol , Aspirin and Codeine Phosphate Tablets, USP CIII Rx only WARNING: May be habit-formingprescriptionHuman PrescriptionEon Labs, Inc.2013-05-204001850749

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