FDA.reportPublic FDA data

Application 205876

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE; ETHINYL ESTRADIOLTABLET;ORAL-283MG;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
A205876-001DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE; ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-282016-09-21

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A205876-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-282016-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205876-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-282016-09-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205876-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-282016-09-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205876-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-282016-09-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A205876-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A205876-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205876-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205876-001AB1ea99ee380514…

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
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLApotex Corp.9187a357-e95d-4733-9627-f19522b863732026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLA-S Medication Solutions6edead7f-a41f-4d0b-a27a-b2047ed4eea02026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: drospirenone and ethinyl estradiol
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA0f8f8a21-cee8-462f-98b3-6c06f2f33e0d2026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: drospirenone and ethinyl estradiol
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA6d85f252-307c-4aa8-9572-1e74c98192832025-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: drospirenone and ethinyl estradiol
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.a8955f3b-afc9-4ef0-8946-9c97ab5b2e052025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
Drospirenone and Ethinyl EstradiolDROSPIRENONE AND ETHINYL ESTRADIOLNorthStar Rx LLCc88c3eb8-3bf5-4004-a7ab-7218cd2f91822025-08-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Drospirenone and Ethinyl Estradiol
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLA-S Medication Solutions9b1f944b-b05b-4ab0-bcf6-42f426b07c452024-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: drospirenone and ethinyl estradiol
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLNaari Pte. Limitedd96f0dd8-4eb9-42f7-ab5e-b5515dcf73d62024-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
Drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.71f90c73-63c2-432b-b112-cbdbd26b965c2023-11-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Drospirenone and ethinyl estradiol
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.25f9b952-cc1d-454e-a3ec-834ba1774b6b2023-09-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DROSPIRENONE AND ETHINYL ESTRADIOL
Drospirenone and Ethinyl EstradiolDROSPIRENONE AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.a1f6ea0e-7c14-47c4-83a2-3797bd012eb42023-09-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Drospirenone and Ethinyl Estradiol
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLProficient Rx LP151048e4-849c-4a66-bf18-c0351e8eefeb2022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: drospirenone 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-4183Drospirenone and ethinyl estradiolDrospirenone and ethinyl estradiolApotex Corp.ANDACurrent
60505-4183Drospirenone and ethinyl estradiolDrospirenone and ethinyl estradiolApotex Corp.ANDACurrent