FDA.reportPublic FDA data

Application 076337

Type
ANDA
Sponsor
VINTAGE PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLAFEM 1/35ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG;1MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076337-001CYCLAFEM 1/35ETHINYL ESTRADIOL; NORETHINDRONE0.035MG;1MGTABLET / ORAL-282010-11-12

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076337-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076337-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076337-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076337-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076337-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076337-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076337-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076337-001AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-7521Cyclafem 1/35norethindrone and ethinyl estradiolPar Pharmaceutical, Inc.ANDACurrent
0603-7521Cyclafem 1/35norethindrone and ethinyl estradiolPar PharmaceuticalANDACurrent
0603-7521Cyclafem 1/35norethindrone and ethinyl estradiolPar PharmaceuticalANDACurrent
53002-1648Cyclafem 1/35norethindrone and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1648Cyclafem 1/35norethindrone and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
76413-105Cyclafem 1/35norethindrone and ethinyl estradiolCentral Texas Community Health CentersANDACurrent