Home Applications 018985 Application 018985
Type NDA
Sponsor JANSSEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORTHO-NOVUM 7/7/7-21 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-21 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG No No 002 ORTHO-NOVUM 7/7/7-28 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG 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 N018985-001 ORTHO-NOVUM 7/7/7-21 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET / ORAL-21 1984-04-04 N018985-002 ORTHO-NOVUM 7/7/7-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1984-04-04
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 N018985-001 ORTHO-NOVUM 7/7/7-21 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET / ORAL-21 1984-04-04 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N018985-002 ORTHO-NOVUM 7/7/7-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1984-04-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018985-001 ORTHO-NOVUM 7/7/7-21 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET / ORAL-21 1984-04-04 e64feba35796…2022-09-29 23:25 UTC 2022-09 N018985-002 ORTHO-NOVUM 7/7/7-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1984-04-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018985-001 ORTHO-NOVUM 7/7/7-21 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET / ORAL-21 1984-04-04 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018985-002 ORTHO-NOVUM 7/7/7-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1984-04-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018985-001 ORTHO-NOVUM 7/7/7-21 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET / ORAL-21 1984-04-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018985-002 ORTHO-NOVUM 7/7/7-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1984-04-04 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-0159 Ortho-Novum norethindrone and ethinyl estradiol A-S Medication Solutions LLC NDA Current 50458-178 Ortho-Novum norethindrone and ethinyl estradiol Janssen Pharmaceuticals, Inc. NDA Current 50458-178 Ortho-Novum norethindrone and ethinyl estradiol Janssen Pharmaceuticals, Inc. NDA Current 50458-178 Ortho-Novum norethindrone and ethinyl estradiol Janssen Pharmaceuticals, Inc. NDA Current 50458-178 Ortho-Novum norethindrone and ethinyl estradiol Janssen Pharmaceuticals, Inc. NDA Current 50458-178 Ortho-Novum norethindrone and ethinyl estradiol Janssen Pharmaceuticals, Inc. NDA Current 52544-165 Necon norethindrone and ethinyl estradiol Actavis Pharma, Inc. NDA Current 68258-5005 Necon 777 norethindrone and ethinyl estradiol Dispensing Solutions, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 49473 SUPPL 2017-08-21 49321 SUPPL 2017-08-10 11402 SUPPL 2015-11-04 1180 SUPPL 2015-11-04 33679 SUPPL 2013-10-04 16158 SUPPL 2013-10-04 16157 SUPPL 2013-10-04 1179 SUPPL 2013-10-04 1178 SUPPL 2013-10-04 11401 SUPPL 2012-07-13 16156 SUPPL 2012-06-20