FDA.reportPublic FDA data

Application 079193

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOL AND NORETHINDRONE ACETATEESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL1MG;0.5MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079193-001ESTRADIOL AND NORETHINDRONE ACETATEESTRADIOL; NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2010-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079193-001AB

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 22:54:322026-06A079193-001ESTRADIOL AND NORETHINDRONE ACETATE1MG;0.5MGTABLET / ORALAB2010-05-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079193-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MimveyESTRADIOL AND NORETHINDRONE ACETATETeva Pharmaceuticals USA, Inc.b1c5c06b-9ce2-4bf7-9693-e37608055a142024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079193
application number: ANDA079193
ndc (product): 0093-5455

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5455MimveyEstradiol and Norethindrone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5455MimveyEstradiol and Norethindrone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5455MimveyEstradiol and Norethindrone AcetateTeva Pharmaceuticals USA,ANDACurrent
0093-5455MimveyEstradiol and Norethindrone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5455MimveyEstradiol and Norethindrone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5455MimveyEstradiol and Norethindrone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5455MimveyEstradiol and Norethindrone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent