Home Applications 075406 Application 075406
Type ANDA
Sponsor WATSON LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OGESTREL 0.5/50-21 ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-21 0.05MG;0.5MG No No 002 OGESTREL 0.5/50-28 ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-28 0.05MG;0.5MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075406-001 OGESTREL 0.5/50-21 ETHINYL ESTRADIOL; NORGESTREL 0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 1999-12-15 A075406-002 OGESTREL 0.5/50-28 ETHINYL ESTRADIOL; NORGESTREL 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15
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 3 of 3 · 88 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 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG TABLET / ORAL-21 1999-12-15 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075406-001 OGESTREL 0.5/50-21 0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 1999-12-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075406-002 OGESTREL 0.5/50-28 0.05MG;0.5MG TABLET / ORAL-28 1999-12-15 a50c72e98297…
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52544-848 Ogestrel Norgestrel and Ethinyl Estradiol Actavis Pharma, Inc. ANDA Current 52544-848 Ogestrel Norgestrel and Ethinyl Estradiol Actavis Pharma, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8654 SUPPL 2013-04-24 39484 SUPPL 2013-04-23 30874 ORIG 1999-12-15