FDA.reportPublic FDA data

Application 214415

Type
ANDA
Sponsor
RUBICON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo
002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo
003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL15MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214415-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2020-10-27
A214415-002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2020-10-27
A214415-003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2020-10-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A214415-001AB
A214415-002AB
A214415-003AB

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 22:54:322026-06A214415-001OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORALAB2020-10-27a50c72e98297…
2026-08-01 22:54:322026-06A214415-002OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2020-10-27a50c72e98297…
2026-08-01 22:54:322026-06A214415-003OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORALAB2020-10-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214415-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A214415-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A214415-003AB1a50c72e98297…

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
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAdvagen Pharma Limited7bd31561-4c76-4c6b-819b-4925498866732026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214415
application number: ANDA214415
ndc (product): 72888-030
ndc (product): 72888-031
ndc (product): 72888-032

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72888-030Oxybutynin ChlorideOxybutynin ChlorideAdvagen Pharma LimitedANDACurrent
72888-030Oxybutynin ChlorideOxybutynin ChlorideAdvagen Pharma LimitedANDACurrent
72888-030Oxybutynin ChlorideOxybutynin ChlorideAdvagen Pharma LimitedANDACurrent
72888-031Oxybutynin ChlorideOxybutynin ChlorideAdvagen Pharma LimitedANDACurrent
72888-031Oxybutynin ChlorideOxybutynin ChlorideAdvagen Pharma LimitedANDACurrent
72888-031Oxybutynin ChlorideOxybutynin ChlorideAdvagen Pharma LimitedANDACurrent
72888-032Oxybutynin ChlorideOxybutynin ChlorideAdvagen Pharma LimitedANDACurrent
72888-032Oxybutynin ChlorideOxybutynin ChlorideAdvagen Pharma LimitedANDACurrent
72888-032Oxybutynin ChlorideOxybutynin ChlorideAdvagen Pharma LimitedANDACurrent