Home Applications 076625 Application 076625
Type ANDA
Sponsor MAYNE PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG No Yes
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 A076625-001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET / ORAL-28 AB1 RS 2004-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076625-001 AB1
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 A076625-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.1MG TABLET / ORAL-28 AB1 RS 2004-11-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076625-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.1MG TABLET / ORAL-28 AB1 RS 2004-11-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076625-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.1MG TABLET / ORAL-28 AB1 RS 2004-11-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A076625-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.1MG TABLET / ORAL-28 AB1 RS 2004-11-18 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 Lutera LEVONORGESTREL AND ETHINYL ESTRADIOL Mayne Pharma Inc. b91ad328-f2f4-4f7d-82d3-daaada95f509 2025-07-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076625 application number: ANDA076625 ndc (product): 51862-028
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 NDC Name Nonproprietary name Labeler Marketing category Status 51862-028 Lutera levonorgestrel and ethinyl estradiol Mayne Pharma Inc. ANDA Current 51862-028 Lutera levonorgestrel and ethinyl estradiol Mayne Pharma Inc. ANDA Current 51862-028 Lutera levonorgestrel and ethinyl estradiol Mayne Pharma Inc. ANDA Current 51862-028 Lutera levonorgestrel and ethinyl estradiol Mayne Pharma Inc. ANDA Current 53002-1632 Lutera levonorgestrel and ethinyl estradiol RPK Pharmaceuticals, Inc. ANDA Current 53002-1632 Lutera levonorgestrel and ethinyl estradiol RPK Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 39512 SUPPL 2012-10-22