Home Applications 022501 Application 022501
Type NDA
Sponsor APIL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LO LOESTRIN FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.01MG,0.01MG;1MG,N/A Yes Yes 002 LO LOESTRIN FE ETHINYL ESTRADIOL TABLET; ORAL 10MCG Yes No 003 LO LOESTRIN FE FERROUS FUMARATE TABLET; ORAL 75MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N022501-001 LO LOESTRIN FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL AB RLD, RS 2010-10-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022501-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022501-001 7704984 2029-02-02 U-1090 2010-10-29
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 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022501-001 LO LOESTRIN FE 0.01MG,0.01MG;1MG,N/A TABLET / ORAL RLD, RS 2010-10-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022501-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022501-001 7704984 2029-02-02 U-1090 2010-10-29 cb3db0bc1861…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0430-0420 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate Allergan, Inc. NDA Current 0430-0420 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate Allergan, Inc. NDA Current 0430-0420 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate Allergan, Inc. NDA Current 0430-0420 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate Allergan, Inc. NDA Current 0430-0420 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate Allergan, Inc. NDA Current 0430-0420 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate Allergan, Inc. NDA Current 0430-0420 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate Allergan, Inc. NDA Current 0430-0420 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate Allergan, Inc. NDA Current 0430-0420 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate Allergan, Inc. NDA Current 50090-1456 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate A-S Medication Solutions NDA Current 50090-1456 Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate A-S Medication Solutions NDA Current