FDA.reportPublic FDA data

Application 077681

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

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

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
A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTREL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077681-001AB2

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-313f01610625f2…
2019-09-15 20:21 UTC2019-09A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077681-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB2RS2006-05-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077681-001AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077681-001AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077681-001AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077681-001AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077681-001AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077681-001AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077681-001AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077681-001AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077681-001AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077681-001AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077681-001AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077681-001AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077681-001AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077681-001AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077681-001AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077681-001AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077681-001AB214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077681-001AB2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077681-001AB21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077681-001AB21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077681-001AB2187673890dc5c…
2021-03-12 10:30 UTC2021-03A077681-001AB215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077681-001AB218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077681-001AB21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077681-001AB213f01610625f2…
2019-09-15 20:21 UTC2019-09A077681-001AB21b00525d2431f…
2019-07-19 19:46 UTC2019-07A077681-001AB21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077681-001AB216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077681-001AB211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077681-001AB21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077681-001AB21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077681-001AB219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077681-001AB21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077681-001AB213f0d92c62455…
2023-05-13 08:27 UTC2023-05A077681-001AB21053a50430f4f…
2023-01-26 05:58 UTC2023-01A077681-001AB213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077681-001AB213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077681-001AB21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077681-001AB21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077681-001AB21cb3db0bc1861…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SRONYXLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.b0c1a495-4cd7-4664-8fe4-714812f53c712025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077681
application number: ANDA077681
ndc (product): 51862-545

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-545SRONYXLevonorgestrel and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-545SRONYXLevonorgestrel and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
53002-1539SRONYXLevonorgestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1539SRONYXLevonorgestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44535ORIG2014-03-20
39539ORIG2014-03-20