Home Applications 077681 Application 077681
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 A077681-001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET / ORAL-28 AB2 RS 2006-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077681-001 AB2
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 A077681-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.1MG TABLET / ORAL-28 AB2 RS 2006-05-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077681-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.1MG TABLET / ORAL-28 AB2 RS 2006-05-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077681-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.1MG TABLET / ORAL-28 AB2 RS 2006-05-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A077681-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.1MG TABLET / ORAL-28 AB2 RS 2006-05-31 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 SRONYX LEVONORGESTREL AND ETHINYL ESTRADIOL Mayne Pharma Inc. b0c1a495-4cd7-4664-8fe4-714812f53c71 2025-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077681 application number: ANDA077681 ndc (product): 51862-545
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 51862-545 SRONYX Levonorgestrel and Ethinyl Estradiol Mayne Pharma Inc. ANDA Current 51862-545 SRONYX Levonorgestrel and Ethinyl Estradiol Mayne Pharma Inc. ANDA Current 53002-1539 SRONYX Levonorgestrel and Ethinyl Estradiol RPK Pharmaceuticals, Inc. ANDA Current 53002-1539 SRONYX Levonorgestrel and Ethinyl Estradiol RPK Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 44535 ORIG 2014-03-20 39539 ORIG 2014-03-20