FDA.reportPublic FDA data

Application 091663

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG;0.15MGNoNo

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
A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTREL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091663-001AB

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A091663-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A091663-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091663-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091663-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091663-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091663-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091663-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091663-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091663-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091663-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091663-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091663-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091663-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091663-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091663-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091663-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091663-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091663-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091663-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091663-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091663-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091663-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091663-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091663-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091663-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091663-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091663-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091663-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091663-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091663-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091663-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091663-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091663-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091663-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091663-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091663-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091663-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091663-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091663-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091663-001AB1f41ea6bd6efb…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.58e85e02-93e7-42ba-b8f5-a36290c684232026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levonorgestrel and Ethinyl Estradiol
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levonorgestrel and Ethinyl Estradiol
levonorgestrel and ethinyl estradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA3d87d9a4-860a-4ea7-a993-0f4adf1789da2026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levonorgestrel and ethinyl estradiol
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e686b50-8d36-4a13-91a8-d4ad21cdb7352025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levonorgestrel and Ethinyl Estradiol
levonorgestrel and ethinyl estradiolLEVONORGESTREL AND ETHINYL ESTRADIOLAcella Pharmaceuticals167b12a0-cdff-4081-a0a4-164482c239fa2025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levonorgestrel and ethinyl estradiol
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.35eb35e6-d9a0-4472-94ac-aa470ccba5672025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levonorgestrel and Ethinyl Estradiol
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedea9f7216-0358-43a9-96eb-5dad694ae9b82024-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levonorgestrel and Ethinyl Estradiol
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf1a3bfe0-1057-4120-be7e-d7b3570d54182024-04-22Warnings, Adverse reactionsName fallback
brand name: Levonorgestrel and Ethinyl Estradiol
LEVONORGESTREL AND ETHINYL ESTRADIOLLEVONORGESTREL AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.c3c00dc0-8834-45fb-9f5b-810a98cef59d2022-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVONORGESTREL 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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLethinyl estradiol and levonorgestrelMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
50102-130CHATEALlevonorgestrel and ethinyl estradiolAfaxys Pharma, LLCANDACurrent
50102-130CHATEALlevonorgestrel and ethinyl estradiolAfaxys Pharma, LLCANDACurrent
50102-130CHATEALlevonorgestrel and ethinyl estradiolAfaxys Pharma, LLCANDACurrent
53002-1683CHATEALlevonorgestrel and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1683CHATEALlevonorgestrel and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent