FDA.reportPublic FDA data

Application 202085

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESOGESTREL AND ETHINYL ESTRADIOLDESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG;0.03MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202085-001DESOGESTREL AND ETHINYL ESTRADIOLDESOGESTREL; ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20c2088c7a36db…
2026-09-14 22:38:342026-08A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-2084e616aacf4f…
2026-08-18 06:07:402026-07A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2015-05-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2015-05-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2015-05-203f01610625f2…
2019-09-15 20:21 UTC2019-09A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2015-05-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-28AB2015-05-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202085-001DESOGESTREL AND ETHINYL ESTRADIOL0.15MG;0.03MGTABLET / ORAL-282015-05-203a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A202085-001AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A202085-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202085-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202085-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202085-001AB1ea99ee380514…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.78454ebf-f1a3-4ca0-b32e-88c51bc577732026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Desogestrel and Ethinyl Estradiol
desogestrel and ethinyl estradiolDESOGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf0323be5-9654-4236-8164-230f51a028cd2024-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: desogestrel and ethinyl estradiol
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.198477e0-855a-4a1d-ae0b-407568dd05f82022-12-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Desogestrel 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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7282DESOGESTREL AND ETHINYL ESTRADIOLdesogestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-7282DESOGESTREL AND ETHINYL ESTRADIOLdesogestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
50102-154CYREDdesogestrel and ethinyl estradiolAfaxys Pharma, LLCANDACurrent
50102-154CYREDdesogestrel and ethinyl estradiolAfaxys Pharma, LLCANDACurrent
53002-1722CYREDdesogestrel and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1722CYREDdesogestrel and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent