FDA.reportPublic FDA data

Application 091232

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRI-LO-ESTARYLLAETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.025MG,0.025MG,0.025MG;0.18MG,0.215MG,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
A091232-001TRI-LO-ESTARYLLAETHINYL ESTRADIOL; NORGESTIMATE0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2015-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091232-001AB

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 22:54:322026-06A091232-001TRI-LO-ESTARYLLA0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2015-06-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091232-001AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack90f7ab24-7839-4408-9a74-07bb6a79eacc2024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091232
application number: ANDA091232
ndc (product): 63629-2351
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3ce752d-58df-363d-e053-2a95a90a54112024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091232
application number: ANDA091232
ndc (product): 42291-565
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.8381db98-f9b2-e894-c07e-5d49f10e4eea2023-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091232
application number: ANDA091232
ndc (product): 70700-120

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-4062Tri-Lo- Estaryllanorgestimate and ethinyl estradiolSandoz IncANDACurrent
42291-565Norgestimate and Ethinyl Estradiolnorgestimate and ethinyl estradiolAvKAREANDACurrent
42291-565Norgestimate and Ethinyl Estradiolnorgestimate and ethinyl estradiolAvKAREANDACurrent
63629-2351Tri-Lo- Estaryllanorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2351Tri-Lo- Estaryllanorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-2351Tri-Lo- Estaryllanorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
70700-120Tri-Lo- Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-120Tri-Lo- Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-120Tri-Lo- Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-120Tri-Lo- Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent
70700-120Tri-Lo- Estaryllanorgestimate and ethinyl estradiolXiromed, LLC.ANDACurrent