FDA.reportPublic FDA data

Application 071994

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 1MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog.

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 4 of 4 · 66 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd33bb132-1b5f-44a2-bc42-e9201cb6566a2023-03-20Warnings, Adverse reactionsName fallback
brand name: Prazosin Hydrochloride
generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloridePRAZOSIN HYDROCHLORIDELifestar Pharma LLC73bbc360-5bfb-4139-a63e-0cb6e4ea83132023-03-17Warnings, Adverse reactionsName fallback
brand name: prazosin hydrochloride
generic name: PRAZOSIN HYDROCHLORIDE
PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEAlembic Pharmaceuticals Limitedfea187a3-ee8b-4463-8485-3b1de15046092023-03-10Warnings, Adverse reactionsName fallback
brand name: PRAZOSIN HYDROCHLORIDE
generic name: PRAZOSIN HYDROCHLORIDE
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEExelan Pharmaceuticalscdde7b22-6b29-4cac-8bd6-f613dab6eef12023-01-26Warnings, Adverse reactionsName fallback
brand name: Prazosin Hydrochloride
generic name: PRAZOSIN HYDROCHLORIDE
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEMylan Pharmaceuticals Inc.1ce90aaf-d075-4617-9a47-e8d922096d232022-09-01Warnings, Adverse reactionsName fallback
brand name: Prazosin Hydrochloride
generic name: PRAZOSIN HYDROCHLORIDE
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDETeva Pharmaceuticals USA, Inc.7293cef3-ef9e-40dc-9995-875ef047f6932018-10-25Warnings, Adverse reactionsName fallback
brand name: Prazosin Hydrochloride
generic name: PRAZOSIN 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
33261-860Prazosin HydrochloridePrazosin HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
64725-4067Prazosin HydrochloridePrazosin HydrochlorideTYA PharmaceuticalsANDACurrent