FDA.reportPublic FDA data

Application 008708

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIBENZYLINEPHENOXYBENZAMINE HYDROCHLORIDECAPSULE;ORAL10MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N008708-001DIBENZYLINEPHENOXYBENZAMINE HYDROCHLORIDE10MGCAPSULE / ORALRLD, Approved before 1982

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N008708-001DIBENZYLINE10MGCAPSULE / ORALABRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N008708-001DIBENZYLINE10MGCAPSULE / ORALABRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N008708-001DIBENZYLINE10MGCAPSULE / ORALABRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N008708-001DIBENZYLINE10MGCAPSULE / ORALRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08N008708-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N008708-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N008708-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N008708-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N008708-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N008708-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N008708-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N008708-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N008708-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N008708-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N008708-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N008708-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N008708-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N008708-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N008708-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N008708-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N008708-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N008708-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N008708-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N008708-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N008708-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N008708-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N008708-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N008708-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N008708-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N008708-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N008708-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N008708-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N008708-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N008708-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N008708-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N008708-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N008708-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N008708-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N008708-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N008708-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N008708-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N008708-001AB1cb3db0bc1861…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenoxybenzamine hydrochloridePHENOXYBENZAMINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLC0be6a394-cd10-42fc-97cf-ad53d81d8d932026-07-03Warnings, Adverse reactionsName fallback
generic name: PHENOXYBENZAMINE HYDROCHLORIDE
phenoxybenzamine hydrochloridePHENOXYBENZAMINE HYDROCHLORIDERising Pharma Holdings, Inc.1d2108fa-4352-4f3f-9314-732ed8b6394c2026-06-18Warnings, Adverse reactionsName fallback
generic name: PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDEBurel Pharmaceuticals, LLC609aa41e-4cb5-4cdf-9137-f429c21b4fab2024-08-09Warnings, Adverse reactionsName fallback
generic name: PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDEAurobindo Pharma Limited75f26681-a079-4ff3-9fff-75526041374c2024-02-16Warnings, Adverse reactionsName fallback
generic name: PHENOXYBENZAMINE HYDROCHLORIDE
Phenoxybenzamine HydrochloridePHENOXYBENZAMINE HYDROCHLORIDENovitium Pharma LLC2cb5fcd7-c37f-41de-8beb-0c7eded9ed042022-10-18Warnings, Adverse reactionsName fallback
generic name: PHENOXYBENZAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59212-001DibenzylinePhenoxybenzamine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-001DibenzylinePhenoxybenzamine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-001DibenzylinePhenoxybenzamine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-001DibenzylinePhenoxybenzamine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-001DibenzylinePhenoxybenzamine HydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
66993-066Phenoxybenzamine HydrochloridePhenoxybenzamine HydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-066Phenoxybenzamine HydrochloridePhenoxybenzamine HydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20015SUPPL2012-02-28
40653SUPPL2011-10-10
32968SUPPL2008-04-16
103SUPPL2008-04-09
157SUPPL2004-06-02
158SUPPL2004-01-09