Home Applications 017876 Application 017876
Type NDA
Sponsor TEVA BRANDED PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOESTRIN 21 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.02MG;1MG 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 N017876-001 LOESTRIN 21 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 RLD, Approved before 1982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 · 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 N017876-001 LOESTRIN 21 1/20 0.02MG;1MG TABLET / ORAL-21 RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N017876-001 LOESTRIN 21 1/20 0.02MG;1MG TABLET / ORAL-21 RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017876-001 LOESTRIN 21 1/20 0.02MG;1MG TABLET / ORAL-21 AB RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017876-001 LOESTRIN 21 1/20 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 RLD, Approved before 1982 a50c72e98297…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 51862-007 MICROGESTIN 1/20 norethindrone acetate and ethinyl estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-007 MICROGESTIN 1/20 norethindrone acetate and ethinyl estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-007 MICROGESTIN 1/20 norethindrone acetate and ethinyl estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-007 MICROGESTIN 1/20 norethindrone acetate and ethinyl estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-007 MICROGESTIN 1/20 norethindrone acetate and ethinyl estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-007 MICROGESTIN 1/20 norethindrone acetate and ethinyl estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-007 MICROGESTIN 1/20 norethindrone acetate and ethinyl estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 53002-1549 MICROGESTIN 1/20 norethindrone acetate and ethinyl estradiol RPK Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 53002-1549 MICROGESTIN 1/20 norethindrone acetate and ethinyl estradiol RPK Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 73107 SUPPL 2023-01-06 73092 SUPPL 2023-01-05 73091 SUPPL 2023-01-05 70964 SUPPL 2022-05-04 70874 SUPPL 2022-05-02 49391 SUPPL 2017-08-15 49337 SUPPL 2017-08-11 735 SUPPL 2003-05-30