FDA.reportPublic FDA data

Application 077077

Type
ANDA
Sponsor
VINTAGE PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GILDESS FE 1/20ETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL-280.02MG;1MGNoNo
002GILDESS 1/20ETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL-210.02MG;1MGNoNo

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
A077077-001GILDESS FE 1/20ETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGTABLET / ORAL-282005-05-20
A077077-002GILDESS 1/20ETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGTABLET / ORAL-212012-07-24

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 22:54:322026-06A077077-001GILDESS FE 1/200.02MG;1MGTABLET / ORAL-282005-05-20a50c72e98297…
2026-08-01 22:54:322026-06A077077-002GILDESS 1/200.02MG;1MGTABLET / ORAL-212012-07-24a50c72e98297…