Home Applications 203371 Application 203371
Type ANDA
Sponsor MYLAN LABS LTD 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 0.025MG;0.8MG 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 A203371-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.025MG;0.8MG TABLET, CHEWABLE / ORAL AB 2014-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203371-001 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 A203371-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.025MG;0.8MG TABLET, CHEWABLE / ORAL AB 2014-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203371-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.025MG;0.8MG TABLET, CHEWABLE / ORAL AB 2014-04-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203371-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.025MG;0.8MG TABLET, CHEWABLE / ORAL AB 2014-04-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203371-001 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.025MG;0.8MG TABLET, CHEWABLE / ORAL AB 2014-04-23 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 GALBRIELA NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Xiromed, LLC 47465e7e-64f2-690b-166e-0e1c3e5bec7a 2024-08-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203371 application number: ANDA203371
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-7308 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE norethindrone and ethinyl estradiol and ferrous fumarate Mylan Pharmaceuticals Inc. ANDA Current