FDA.reportPublic FDA data

Application 077075

Type
ANDA
Sponsor
VINTAGE PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GILDESS FE 1.5/30ETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL-280.03MG;1.5MGNoNo
002GILDESS 1.5/30ETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL-210.03MG;1.5MGNoNo

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
A077075-001GILDESS FE 1.5/30ETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.03MG;1.5MGTABLET / ORAL-282005-04-28
A077075-002GILDESS 1.5/30ETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.03MG;1.5MGTABLET / 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 22:54:322026-06A077075-001GILDESS FE 1.5/300.03MG;1.5MGTABLET / ORAL-282005-04-28a50c72e98297…
2026-08-01 22:54:322026-06A077075-002GILDESS 1.5/300.03MG;1.5MGTABLET / ORAL-212012-07-24a50c72e98297…