FDA.reportPublic FDA data

Application 077006

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOLTERODINE TARTRATETOLTERODINE TARTRATETABLET;ORAL1MGNoNo
002TOLTERODINE TARTRATETOLTERODINE TARTRATETABLET;ORAL2MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077006-001TOLTERODINE TARTRATETOLTERODINE TARTRATE1MGTABLET / ORALAB2015-02-23
A077006-002TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGTABLET / ORALAB2015-02-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077006-001AB
A077006-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077006-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2015-02-23a50c72e98297…
2026-08-01 22:54:322026-06A077006-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2015-02-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077006-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077006-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolterodine TartrateTOLTERODINE TARTRATETeva Pharmaceuticals USA, Inc.d27e25b5-5d02-419f-b098-41fb162c58722022-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077006
application number: ANDA077006
ndc (product): 0093-0018
ndc (product): 0093-0010
Tolterodine TartrateTOLTERODINE TARTRATEProficient Rx LPb77f9893-a422-423a-bb27-527377ade36d2019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077006
application number: ANDA077006
ndc (product): 71205-319

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0010Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0010Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0010Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0018Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0018Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0018Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
68151-3549Tolterodine TartrateTolterodine TartrateCarilion Materials ManagementANDACurrent
70518-1873Tolterodine TartrateTolterodine TartrateREMEDYREPACK INC.ANDACurrent
71205-319Tolterodine TartrateTolterodine TartrateProficient Rx LPANDACurrent