FDA.reportPublic FDA data

Application 076629

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL-280.02MG,0.03MG,0.035MG;1MG,1MG,1MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-1884e616aacf4f…
2026-08-18 06:07:402026-07A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-28AB2010-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-28AB2010-03-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-28AB2010-03-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-28AB2010-03-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-28AB2010-03-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-28AB2010-03-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-28AB2010-03-183f01610625f2…
2019-09-15 20:21 UTC2019-09A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-28AB2010-03-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-28AB2010-03-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076629-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG,0.03MG,0.035MG;1MG,1MG,1MGTABLET / ORAL-282010-03-18f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076629-001AB174a2ff9319b5…
2021-12-28 21:50 UTC2021-12A076629-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076629-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076629-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076629-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076629-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076629-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076629-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076629-001AB1ea99ee380514…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLA-S Medication Solutions38924c83-53aa-4279-8f0e-1a5d8f5fd8ad2026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norethindrone Acetate and Ethinyl Estradiol
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5a44f7a2-45f1-4d28-b9fb-61d9f24564222026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norethindrone Acetate and Ethinyl Estradiol
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norethindrone Acetate and Ethinyl Estradiol
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.89948751-bd6e-4e9c-b87c-8782706c10972024-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.4423eebd-6397-4330-85a8-baa2e736767a2023-11-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETSXiromed, LLCb4bc4302-9484-465a-090d-47e1e0360b732023-07-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norethindrone Acetate and Ethinyl Estradiol

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-685Tilia FeNorethindrone Acetate and Ethinyl EstradiolRebel Distributors CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31145ORIG2010-03-22