Home Applications 204426 Application 204426
Type NDA
Sponsor APIL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TAYTULLA ETHINYL ESTRADIOL; NORETHINDRONE ACETATE CAPSULE;ORAL 0.02MG;1MG Yes Yes
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 N204426-001 TAYTULLA ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N204426-001 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 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 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL RLD, RS 2013-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL RLD, RS 2013-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL RLD, RS 2013-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL RLD, RS 2013-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL RLD, RS 2013-04-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204426-001 TAYTULLA 0.02MG;1MG CAPSULE / ORAL AB RLD, RS 2013-04-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N204426-001 6652880 2020-03-29 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N204426-001 6652880 2020-03-29 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204426-001 6652880 2020-03-29 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204426-001 6652880 2020-03-29 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204426-001 6652880 2020-03-29 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204426-001 6652880 2020-03-29 Drug product ea99ee380514…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Taytulla NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE Allergan, Inc. 2fa8e8dc-f7b0-429a-b554-0e3c4291c92c 2024-10-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 204426 application number: NDA204426 ndc (product): 0023-5862
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-5862 Taytulla norethindrone acetate and ethinyl estradiol, and ferrous fumarate Allergan, Inc. NDA Current 0023-5862 Taytulla norethindrone acetate and ethinyl estradiol, and ferrous fumarate Allergan, Inc. NDA Current 0023-5862 Taytulla norethindrone acetate and ethinyl estradiol, and ferrous fumarate Allergan, Inc. NDA Current 0023-5862 Taytulla norethindrone acetate and ethinyl estradiol, and ferrous fumarate Allergan, Inc. NDA Current 0430-0539 norethindrone acetate and ethinyl estradiol and ferrous fumarate norethindrone acetate and ethinyl estradiol, and ferrous fumarate Warner Chilcott (US), LLC NDA Current 59762-1599 norethindrone acetate and ethinyl estradiol and ferrous fumarate norethindrone acetate and ethinyl estradiol, and ferrous fumarate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1599 norethindrone acetate and ethinyl estradiol and ferrous fumarate norethindrone acetate and ethinyl estradiol, and ferrous fumarate Greenstone LLC NDA Current