Home Applications 017355 Application 017355
Type NDA
Sponsor TEVA BRANDED PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOESTRIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.03MG;1.5MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N017355-001 LOESTRIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET / ORAL-21 RLD, Approved before 1982
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 · 43 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 2022-09-29 23:25 UTC 2022-09 N017355-001 LOESTRIN FE 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017355-001 LOESTRIN FE 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017355-001 LOESTRIN FE 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51862-292 MICROGESTIN Fe 1.5/30 norethindrone acetate and ethinyl estradiol and ferrous fumarate Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-292 MICROGESTIN Fe 1.5/30 norethindrone acetate and ethinyl estradiol and ferrous fumarate Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-292 MICROGESTIN Fe 1.5/30 norethindrone acetate and ethinyl estradiol and ferrous fumarate Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-292 MICROGESTIN Fe 1.5/30 norethindrone acetate and ethinyl estradiol and ferrous fumarate Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-292 MICROGESTIN Fe 1.5/30 norethindrone acetate and ethinyl estradiol and ferrous fumarate Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-292 MICROGESTIN Fe 1.5/30 norethindrone acetate and ethinyl estradiol and ferrous fumarate Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-292 MICROGESTIN Fe 1.5/30 norethindrone acetate and ethinyl estradiol and ferrous fumarate Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-292 MICROGESTIN Fe 1.5/30 norethindrone acetate and ethinyl estradiol and ferrous fumarate Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 53002-1567 MICROGESTIN Fe 1.5/30 norethindrone acetate and ethinyl estradiol and ferrous fumarate RPK Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 73104 SUPPL 2023-01-06 73097 SUPPL 2023-01-05 70966 SUPPL 2022-05-04 70879 SUPPL 2022-05-02 49394 SUPPL 2017-08-15 49335 SUPPL 2017-08-11 13110 SUPPL 2003-07-31