Application 216936

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DROSPIRENONEDROSPIRENONETABLET;ORAL4MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216936-001DROSPIRENONE4MGTABLET / ORALAB2024-09-302680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216936-001DROSPIRENONE4MGTABLET / ORALAB2024-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216936-001DROSPIRENONE4MGTABLET / ORALAB2024-09-30d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216936-001AB12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216936-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216936-001AB1d06236e962d9…

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
SLYNDDROSPIRENONEExeltis USA, Inc.db32bc55-f295-4d87-9dbb-0a2f45573dcf2025-07-01Warnings, Adverse reactionsName fallback
generic name: DROSPIRENONE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72953ORIG2022-12-20