Home Applications 078892 Application 078892
Type ANDA
Sponsor AMNEAL PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE TABLET, CHEWABLE;ORAL 0.035MG;0.4MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078892-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET / ORAL AB 2011-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078892-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A078892-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2011-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078892-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2011-09-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078892-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2011-09-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078892-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG TABLET / ORAL AB 2011-09-26 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zenchent FE NORETHINDRONE AND ETHINYL ESTRADIOL Amneal Pharmaceuticals NY LLC 17a9750b-e1b0-4293-992d-195b2eb9ea11 2022-05-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078892 application number: ANDA078892 ndc (product): 69238-1581
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65162-347 Zenchent FE Norethindrone and Ethinyl Estradiol Amneal Pharmaceuticals of New York, LLC ANDA Current 69238-1581 Zenchent FE Norethindrone and Ethinyl Estradiol Amneal Pharmaceuticals NY LLC ANDA Current