Home Applications 076783 Application 076783
Type ANDA
Sponsor BARR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARANELLE ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG No No 002 ARANELLE NORETHINDRONE; ETHINYL ESTRADIOL TABLET; ORAL 1MG/0.035MG 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 A076783-001 ARANELLE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-28 AB 2004-09-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076783-001 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 A076783-001 ARANELLE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-28 AB 2004-09-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076783-001 ARANELLE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-28 AB 2004-09-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076783-001 ARANELLE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-28 AB 2004-09-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A076783-001 ARANELLE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-28 AB 2004-09-29 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 Aranelle NORETHINDRONE AND ETHINYL ESTRADIOL Teva Pharmaceuticals USA, Inc. 0beef9d3-8326-48cf-b89a-fa794902c6c1 2023-01-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076783 application number: ANDA076783 ndc (product): 0555-9066
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0555-9066 Aranelle norethindrone and ethinyl estradiol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-9066 Aranelle norethindrone and ethinyl estradiol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-9066 Aranelle norethindrone and ethinyl estradiol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-9066 Aranelle norethindrone and ethinyl estradiol Teva Pharmaceuticals USA, Inc. ANDA Current