Home Applications 021065 Application 021065
Type NDA
Sponsor APIL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FEMHRT ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.0025MG;0.5MG No No 002 FEMHRT ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No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 43 .
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 N021065-001 FEMHRT ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-01-14 N021065-002 FEMHRT ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15
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 3 · 86 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 2022-03-09 01:35 UTC 2022-03 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-10-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL AB 2005-01-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-10-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL AB 2005-01-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-10-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL AB 2005-01-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-10-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL AB 2005-01-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-10-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL AB 2005-01-14 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-10-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL AB 2005-01-14 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-10-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL AB 2005-01-14 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-10-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 f41ea6bd6efb…
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0430-0145 femhrt norethindrone acetate/ethinyl estradiol Allergan, Inc. NDA Current 0430-0145 femhrt norethindrone acetate/ethinyl estradiol Allergan, Inc. NDA Current 52544-236 Jevantique Lo Norethindrone Acetate and Ethinyl Estradiol Actavis Pharma, Inc. NDA Current