FDA.reportPublic FDA data

Application 075079

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET;ORAL5MGNoYes
002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET;ORAL2.5MGNoNo

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
A075079-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1997-10-31
A075079-002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE2.5MGTABLET / ORALAB2026-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075079-001AB
A075079-002AB

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 22:54:322026-06A075079-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1997-10-31a50c72e98297…
2026-08-01 22:54:322026-06A075079-002OXYBUTYNIN CHLORIDE2.5MGTABLET / ORALAB2026-03-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075079-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075079-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEStrides Pharma Science Limited9ede5def-d185-4e40-9c10-8663ac654caf2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075079
application number: ANDA075079
ndc (product): 64380-162
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC2425f49f-ade3-5178-e063-6294a90adfac2024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075079
application number: ANDA075079

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-4975Oxybutynin Chlorideoxybutynin chloridePar PharmaceuticalANDACurrent
0603-4975Oxybutynin Chlorideoxybutynin chloridePar Pharmaceutical, Inc.ANDACurrent
0615-3512Oxybutynin ChlorideOxybutynin ChlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-3512Oxybutynin ChlorideOxybutynin ChlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8428Oxybutynin Chlorideoxybutynin chlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-518Oxybutynin Chlorideoxybutynin chlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-406Oxybutynin Chlorideoxybutynin chlorideRebel Distributors Corp.ANDACurrent
33261-342Oxybutynin Chlorideoxybutynin chlorideAidarex Pharmaceuticals LLCANDACurrent
42291-914Oxybutynin Chlorideoxybutynin chlorideAvKAREANDACurrent
43063-145Oxybutynin Chlorideoxybutynin chloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-367Oxybutynin Chlorideoxybutynin chlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-367Oxybutynin Chlorideoxybutynin chlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2049Oxybutynin Chlorideoxybutynin chlorideA-S Medication SolutionsANDACurrent
50090-2049Oxybutynin Chlorideoxybutynin chlorideA-S Medication SolutionsANDACurrent
53808-0618Oxybutynin Chlorideoxybutynin chlorideState of Florida DOH Central PharmacyANDACurrent
55154-6647Oxybutynin Chlorideoxybutynin chlorideCardinal HealthANDACurrent
55154-6647Oxybutynin Chlorideoxybutynin chlorideCardinal HealthANDACurrent
55154-6647Oxybutynin Chlorideoxybutynin chlorideCardinal HealthANDACurrent
60687-670Oxybutynin Chlorideoxybutynin chlorideAmerican Health PackagingANDACurrent
63629-1354Oxybutynin Chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
63629-1354Oxybutynin Chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
63629-2244Oxybutynin Chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
63629-2244Oxybutynin Chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
63629-2245Oxybutynin Chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
63629-2245Oxybutynin Chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
63629-2246Oxybutynin Chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
63629-2246Oxybutynin Chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
63629-8996Oxybutynin Chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
64380-162Oxybutynin Chlorideoxybutynin chlorideStrides Pharma Science LimitedANDACurrent
64380-162Oxybutynin Chlorideoxybutynin chlorideStrides Pharma Science LimitedANDACurrent
64380-162Oxybutynin Chlorideoxybutynin chlorideStrides Pharma Science LimitedANDACurrent
68071-1959Oxybutynin Chlorideoxybutynin chlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68084-400Oxybutynin Chlorideoxybutynin chlorideAmerican Health PackagingANDACurrent
68084-400Oxybutynin Chlorideoxybutynin chlorideAmerican Health PackagingANDACurrent
68084-400Oxybutynin Chlorideoxybutynin chlorideAmerican Health PackagingANDACurrent
68788-6402Oxybutynin Chlorideoxybutynin chloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0856Oxybutynin Chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-0856Oxybutynin Chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-1030Oxybutynin Chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-1030Oxybutynin Chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent