Home Applications 020713 Application 020713
Type NDA
Sponsor TEVA BRANDED PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIRCETTE DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No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 N020713-001 MIRCETTE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1998-04-22
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 N020713-001 MIRCETTE 0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1998-04-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020713-001 MIRCETTE 0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1998-04-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020713-001 MIRCETTE 0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1998-04-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020713-001 MIRCETTE 0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1998-04-22 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 73103 SUPPL 2023-01-06 73094 SUPPL 2023-01-05 70930 SUPPL 2022-05-03 70909 SUPPL 2022-05-03 49369 SUPPL 2017-08-15 49329 SUPPL 2017-08-10 3180 SUPPL 2012-07-20 13277 SUPPL 2012-07-19 20872 ORIG 1998-04-22