Home Applications 200490 Application 200490
Type ANDA
Sponsor MYLAN LABS LTD 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 0.03MG;0.15MG 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 A200490-001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET / ORAL AB 2015-04-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200490-001 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 A200490-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.03MG;0.15MG TABLET / ORAL AB 2015-04-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200490-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.03MG;0.15MG TABLET / ORAL AB 2015-04-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200490-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.03MG;0.15MG TABLET / ORAL AB 2015-04-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A200490-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.03MG;0.15MG TABLET / ORAL AB 2015-04-21 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 INTROVALE LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS Xiromed LLC 24abb5e1-5be4-87e7-404c-d8c2db25ffd0 2024-10-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200490 application number: ANDA200490
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-7281 LEVONORGESTREL AND ETHINYL ESTRADIOL Levonorgestrel and Ethinyl Estradiol Mylan Pharmaceuticals Inc. ANDA Current 0378-7281 LEVONORGESTREL AND ETHINYL ESTRADIOL Levonorgestrel and Ethinyl Estradiol Mylan Pharmaceuticals Inc. ANDA Current 0378-7281 LEVONORGESTREL AND ETHINYL ESTRADIOL Levonorgestrel and Ethinyl Estradiol Mylan Pharmaceuticals Inc. ANDA Current