FDA.reportPublic FDA data

Application 079141

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOLTERODINE TARTRATETOLTERODINE TARTRATECAPSULE, EXTENDED RELEASE;ORAL2MGNoNo
002TOLTERODINE TARTRATETOLTERODINE TARTRATECAPSULE, EXTENDED RELEASE;ORAL4MGNoNo

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
A079141-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22
A079141-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079141-001AB
A079141-002AB

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 22:54:322026-06A079141-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22a50c72e98297…
2026-08-01 22:54:322026-06A079141-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079141-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079141-002AB1a50c72e98297…

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 TARTRATEA-S Medication Solutionsfd6c8b3d-a52a-4418-aa9c-0297db6c08072026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079141
application number: ANDA079141
ndc (product): 50090-3475
Tolterodine TartrateTOLTERODINE TARTRATETeva Pharmaceuticals USA, Inc.973f98b5-4e8a-42d9-ac69-d4333d21c3622024-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079141
application number: ANDA079141
ndc (product): 0093-7164
ndc (product): 0093-7163

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7163Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7163Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7163Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7163Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7163Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7163Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7164Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7164Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7164Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7164Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7164Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7164Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-3475Tolterodine TartrateTolterodine TartrateA-S Medication SolutionsANDACurrent
50090-3475Tolterodine TartrateTolterodine TartrateA-S Medication SolutionsANDACurrent
50090-3475Tolterodine TartrateTolterodine TartrateA-S Medication SolutionsANDACurrent
50090-5995Tolterodine TartrateTolterodine TartrateA-S Medication SolutionsANDACurrent