FDA.reportPublic FDA data

Application 206120

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET, CHEWABLE;ORAL0.02MG;1MGNoNo

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
A206120-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGTABLET / ORAL2017-09-12

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206120-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGTABLET / ORAL2017-09-12a50c72e98297…

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
Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEGlenmark Pharmaceuticals Inc., USA3e608414-5e64-4c69-a9e0-365904cf7df82026-01-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAmneal Pharmaceuticals NY LLCd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab2023-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEMylan Pharmaceuticals Inc.054917fa-573b-4b16-a719-ece6c09096562021-11-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
norethindrone acetate and ethinyl estradiol and ferrous fumarateNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEGlenmark Pharmaceuticals Inc., USA570670c0-b88f-4e78-a978-498aff52b4102017-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: norethindrone acetate and ethinyl estradiol and ferrous fumarate

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7315NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEnorethindrone acetate and ethinyl estradiol and ferrous fumarateMylan Pharmaceuticals Inc.ANDACurrent