Application 213406

Type
ANDA
Sponsor
APPCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 1MG BASENoNo
002PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 2MG BASENoNo
003PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70377-066Prazosin hydrochloridePrazosin hydrochlorideBiocon Pharma Inc.ANDACurrent
70377-067Prazosin hydrochloridePrazosin hydrochlorideBiocon Pharma Inc.ANDACurrent
70377-068Prazosin hydrochloridePrazosin hydrochlorideBiocon Pharma Inc.ANDACurrent