FDA.reportPublic FDA data

Application 204522

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDECAPSULE;ORAL10MGNoYes

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

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
A204522-001PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDE10MGCAPSULE / ORALABRS2017-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204522-001AB

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 22:54:322026-06A204522-001PHENOXYBENZAMINE HYDROCHLORIDE10MGCAPSULE / ORALABRS2017-01-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204522-001AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDENorthStar Rx LLC48a047c0-f409-420b-990a-2cab953a96cd2026-07-09Warnings, Adverse reactionsName fallback
brand name: PHENOXYBENZAMINE HYDROCHLORIDE
generic name: PHENOXYBENZAMINE HYDROCHLORIDE
Phenoxybenzamine hydrochloridePHENOXYBENZAMINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLC0be6a394-cd10-42fc-97cf-ad53d81d8d932026-07-03Warnings, Adverse reactionsName fallback
brand name: Phenoxybenzamine hydrochloride
generic name: PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDEBurel Pharmaceuticals, LLC609aa41e-4cb5-4cdf-9137-f429c21b4fab2024-08-09Warnings, Adverse reactionsName fallback
brand name: PHENOXYBENZAMINE HYDROCHLORIDE
generic name: PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDEAurobindo Pharma Limited75f26681-a079-4ff3-9fff-75526041374c2024-02-16Warnings, Adverse reactionsName fallback
brand name: PHENOXYBENZAMINE HYDROCHLORIDE
generic name: PHENOXYBENZAMINE HYDROCHLORIDE
Phenoxybenzamine HydrochloridePHENOXYBENZAMINE HYDROCHLORIDENovitium Pharma LLC2cb5fcd7-c37f-41de-8beb-0c7eded9ed042022-10-18Warnings, Adverse reactionsName fallback
brand name: Phenoxybenzamine Hydrochloride
generic name: PHENOXYBENZAMINE HYDROCHLORIDE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-038Phenoxybenzamine HydrochloridePhenoxybenzamine HydrochloridePar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47006ORIG2017-01-30