Application 208247

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROFLUMILASTROFLUMILASTTABLET;ORAL500MCGNoNo
002ROFLUMILASTROFLUMILASTTABLET;ORAL250MCGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208247-001ROFLUMILASTROFLUMILAST500MCGTABLET / ORALAB2020-03-30
A208247-002ROFLUMILASTROFLUMILAST250MCGTABLET / ORALAB2023-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A208247-001AB
A208247-002AB

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
2026-08-01 22:54:322026-06A208247-001ROFLUMILAST500MCGTABLET / ORALAB2020-03-30a50c72e98297…
2026-08-01 22:54:322026-06A208247-002ROFLUMILAST250MCGTABLET / ORALAB2023-06-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208247-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208247-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
roflumilastROFLUMILASTAvKARE55009549-3f0c-1f58-e063-6294a90a6c032026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208247
application number: ANDA208247

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
64380-786roflumilastROFLUMILASTStrides Pharma Science LimitedANDACurrent
64380-786roflumilastROFLUMILASTStrides Pharma Science LimitedANDACurrent