FDA.reportPublic FDA data

Application 207065

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.02MG;0.1MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTREL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207065-001AB1

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2020-08-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2020-08-174b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2020-08-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2020-08-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2020-08-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2020-08-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2020-08-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2020-08-17c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207065-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207065-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207065-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207065-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207065-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207065-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207065-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207065-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207065-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207065-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207065-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207065-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207065-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207065-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207065-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207065-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207065-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207065-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207065-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207065-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207065-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207065-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207065-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207065-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207065-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207065-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207065-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207065-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207065-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207065-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A207065-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A207065-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207065-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207065-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207065-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207065-001AB11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207065-001AB11a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLApotex Corp.a7a1fb54-5a24-40ff-b862-dea256309b7d2026-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207065
application number: ANDA207065
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf1a3bfe0-1057-4120-be7e-d7b3570d54182024-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207065
application number: ANDA207065
ndc (product): 79929-004

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
79929-004Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolNaari Pte LimitedANDACurrent