FDA.reportPublic FDA data

Application 079014

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A079014-001ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-18

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A079014-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079014-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A079014-001ALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2011-07-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A079014-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079014-001AB1ea99ee380514…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEApotex Corp.26fcc267-c8d7-e059-1bcf-830dded436902026-09-03Warnings, Adverse reactionsName fallback
brand name: Alfuzosin Hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEAurobindo Pharma Limitedd163369b-e44b-4591-b166-7ddd0c1c13c02026-07-15Warnings, Adverse reactionsName fallback
brand name: Alfuzosin Hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEAurobindo Pharma Limited8811cb59-6826-41d5-ab68-567338a4b8832026-07-07Warnings, Adverse reactionsName fallback
brand name: Alfuzosin Hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepack37e89394-af6e-4700-bfa8-2effba1a286b2026-05-07Warnings, Adverse reactionsName fallback
brand name: Alfuzosin Hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDENorthwind Health Company, LLCf2f42c98-4118-5f70-e053-2a95a90add022026-01-01Warnings, Adverse reactionsName fallback
brand name: Alfuzosin Hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDENorthwind Health Company, LLCffbd22eb-9df5-e0ad-e053-6294a90a7d4e2026-01-01Warnings, Adverse reactionsName fallback
brand name: Alfuzosin hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDERising Pharma Holdings, Inc.43675e9d-a361-4109-9ae1-54d80580fbbd2026-01-01Warnings, Adverse reactionsName fallback
brand name: Alfuzosin Hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDENorthwind Health Company, LLCf2a530bd-6a86-251d-e053-2995a90adac42025-12-26Warnings, Adverse reactionsName fallback
brand name: Alfuzosin Hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepack3a541efa-9eed-4a27-b602-7999fc6f59aa2024-07-16Warnings, Adverse reactionsName fallback
brand name: Alfuzosin Hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepackc01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda2024-05-23Warnings, Adverse reactionsName fallback
brand name: Alfuzosin hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDEBryant Ranch Prepack98fa10c2-7c12-44aa-9112-e2fd6fa71d062024-04-03Warnings, Adverse reactionsName fallback
brand name: Alfuzosin Hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin HydrochlorideALFUZOSIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.d2af616e-673a-4fdd-ace8-db2d0f1546042024-01-19Warnings, Adverse reactionsName fallback
brand name: Alfuzosin Hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEExelan Pharmaceuticals Inc.f075a897-7bef-4799-b7e2-7e051c4614432023-10-01Warnings, Adverse reactionsName fallback
brand name: Alfuzosin hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.644295a9-75cb-4326-a71f-b0f4e0c4cf752022-03-25Warnings, Adverse reactionsName fallback
brand name: Alfuzosin hydrochloride
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin Hydrochloride extended releaseALFUZOSIN HYDROCHLORIDECipla USA Inc.3cc028d5-309f-4ce3-a2d7-5804ab57677d2020-10-01Warnings, Adverse reactionsName fallback
generic name: ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochlorideALFUZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC790fe381-4a83-402e-b6c0-2ecde9cac7a72017-12-19Warnings, Adverse reactionsName fallback
brand name: Alfuzosin hydrochloride
generic name: ALFUZOSIN 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-5005Alfuzosin HydrochloridealfuzosinMylan Pharmaceuticals Inc.ANDACurrent
43353-746Alfuzosin HydrochloridealfuzosinAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31404ORIG2011-07-20