FDA.reportPublic FDA data

Application 201896

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG;0.25MGNoNo

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
A201896-001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATE0.035MG;0.25MGTABLET / ORAL-282016-01-27

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 UTC2022-09A201896-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-282016-01-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201896-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-282016-01-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201896-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-282016-01-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A201896-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201896-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A201896-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201896-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201896-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201896-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201896-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201896-001AB1ea99ee380514…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: norgestimate and ethinyl estradiol
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions35c6507c-555a-45ed-aaf6-8695831de71a2026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate and Ethinyl Estradiol
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA8b247e46-203e-4f5b-b5a7-cbd57341c7352026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate and Ethinyl Estradiol
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e8bec6f-17ba-4b37-ae6c-07657815f2482025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate and ethinyl estradiol
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.c25cd86c-2940-475a-9628-ee75b0294e8d2025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate and Ethinyl Estradiol
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.00dd9b78-dd90-414b-b241-7619aa9d1ed22025-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate and Ethinyl Estradiol
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limitedb936a6fb-27ed-44de-9199-8c656bcd366e2024-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate and ethinyl estradiol
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limited03de435b-b8fb-4faa-a0ec-01e48b5aaae42024-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate and ethinyl estradiol
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3c0c983-7ec7-244a-e053-2995a90adbe42024-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate and Ethinyl Estradiol
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3ce752d-58df-363d-e053-2a95a90a54112024-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate and Ethinyl Estradiol
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3cfd79e-a344-1dfc-e053-2995a90a1ab72024-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: norgestimate and ethinyl estradiol
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions6ae97238-28cf-4bc9-a4ba-1e2bf4e3c6002023-03-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate and Ethinyl Estradiol
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4a159dcd-8af4-4e59-8f46-7b0fe5c228072022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norgestimate 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
0378-7286NORGESTIMATE AND ETHINYL ESTRADIOLnorgestimate and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent