Home Applications 018977 Application 018977
Type NDA
Sponsor MAYNE PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRI-NORINYL 21-DAY ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-21 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG No No 002 TRI-NORINYL 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG Yes 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 N018977-001 TRI-NORINYL 21-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-21 1984-04-13 N018977-002 TRI-NORINYL 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-28 AB RLD, RS 1984-04-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018977-002 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 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 N018977-001 TRI-NORINYL 21-DAY 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-21 1984-04-13 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N018977-002 TRI-NORINYL 28-DAY 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-28 AB RLD, RS 1984-04-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018977-001 TRI-NORINYL 21-DAY 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-21 1984-04-13 e64feba35796…2022-09-29 23:25 UTC 2022-09 N018977-002 TRI-NORINYL 28-DAY 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-28 AB RLD, RS 1984-04-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018977-001 TRI-NORINYL 21-DAY 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-21 1984-04-13 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018977-002 TRI-NORINYL 28-DAY 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-28 AB RLD, RS 1984-04-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018977-001 TRI-NORINYL 21-DAY 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-21 1984-04-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018977-002 TRI-NORINYL 28-DAY 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET / ORAL-28 AB RLD, RS 1984-04-13 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51862-470 Tri-Norinyl Norethindrone and Ethinyl Estradiol Mayne Pharma Inc. NDA Current 51862-471 Leena Norethindrone and Ethinyl Estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-471 Leena Norethindrone and Ethinyl Estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current 51862-471 Leena Norethindrone and Ethinyl Estradiol Mayne Pharma Inc. NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 70923 SUPPL 2022-05-03 70894 SUPPL 2022-05-02 49399 SUPPL 2017-08-15 49328 SUPPL 2017-08-10