FDA.reportPublic FDA data

Application 075140

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 5MG BASENoNo
002TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 1MG BASENoNo
003TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 2MG BASENoNo
004TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1570Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousMylan Pharmaceuticals Inc.ANDACurrent
0378-2260Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousMylan Pharmaceuticals Inc.ANDACurrent
0378-2264Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousMylan Pharmaceuticals Inc.ANDACurrent
0378-2268Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousMylan Pharmaceuticals Inc.ANDACurrent
43063-495Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousPD-Rx Pharmaceuticals, Inc.ANDACurrent
51079-936Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousMylan Institutional Inc.ANDACurrent
51079-936Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousMylan Institutional Inc.ANDACurrent
51079-937Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousMylan Institutional Inc.ANDACurrent
51079-937Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousMylan Institutional Inc.ANDACurrent
51079-938Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousMylan Institutional Inc.ANDACurrent
51079-938Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousMylan Institutional Inc.ANDACurrent
71335-0787Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousBryant Ranch PrepackANDACurrent
71335-0787Terazosin Hydrochloride Anhydrousterazosin hydrochloride anhydrousBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22430ORIG2004-06-18
18390ORIG2004-06-18
8536ORIG2004-06-18
30772ORIG2000-02-11