FDA.reportPublic FDA data

Application 090794

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTARYLLAETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG;0.25MGNoNo

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
A090794-001ESTARYLLAETHINYL ESTRADIOL; NORGESTIMATE0.035MG;0.25MGTABLET / ORAL-28AB2013-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090794-001AB

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 22:54:322026-06A090794-001ESTARYLLA0.035MG;0.25MGTABLET / ORAL-28AB2013-01-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090794-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP7acde5ef-f457-4c47-897b-d048194c7d7e2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090794
application number: ANDA090794
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepacke0b07fb6-8dbd-4e5d-b589-5191a1dc02ae2024-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090794
application number: ANDA090794
ndc (product): 63629-2349
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3c0c983-7ec7-244a-e053-2995a90adbe42024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090794
application number: ANDA090794
ndc (product): 42291-553
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.7a4d2d7b-b97e-3e18-3d97-1e2579c8f3f82023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090794
application number: ANDA090794
ndc (product): 70700-119

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0254-2029PrevifemNorgestimate and ethinyl estradiolPar Pharmaceutical, Inc.ANDACurrent
0254-2029PrevifemNorgestimate and ethinyl estradiolPar Pharmaceutical, Inc.ANDACurrent
0781-4058EstaryllaNorgestimate and ethinyl estradiolSandoz IncANDACurrent
42291-553Norgestimate and Ethinyl EstradiolNorgestimate and ethinyl estradiolAvKAREANDACurrent
42291-553Norgestimate and Ethinyl EstradiolNorgestimate and ethinyl estradiolAvKAREANDACurrent
53002-2191PrevifemNorgestimate and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
63629-2349EstaryllaNorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2349EstaryllaNorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2349EstaryllaNorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
70518-2010PrevifemNorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-2010PrevifemNorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-2010PrevifemNorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70700-119EstaryllaNorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-119EstaryllaNorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-119EstaryllaNorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent