FDA.reportPublic FDA data

Application 075317

Type
ANDA
Sponsor
JUBILANT CADISTA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-812Terazosin HydrochlorideTerazosin HydrochlorideRebel Distributors CorpANDACurrent
21695-813Terazosin HydrochlorideTerazosin HydrochlorideRebel Distributors CorpANDACurrent
42291-820TerazosinTerazosin HydrochlorideAvKAREANDACurrent
42291-820TerazosinTerazosin HydrochlorideAvKAREANDACurrent
42291-821TerazosinTerazosin HydrochlorideAvKAREANDACurrent
42291-821TerazosinTerazosin HydrochlorideAvKAREANDACurrent
42291-822TerazosinTerazosin HydrochlorideAvKAREANDACurrent
42291-822TerazosinTerazosin HydrochlorideAvKAREANDACurrent
42291-823TerazosinTerazosin HydrochlorideAvKAREANDACurrent
42291-823TerazosinTerazosin HydrochlorideAvKAREANDACurrent
49999-227Terazosin HydrochlorideTerazosin HydrochlorideQuality Care Products LLCANDACurrent
49999-227Terazosin HydrochlorideTerazosin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-227Terazosin HydrochlorideTerazosin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-227Terazosin HydrochlorideTerazosin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0657TerazosinTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-1559TerazosinTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-1559TerazosinTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2371TerazosinTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2371TerazosinTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2371TerazosinTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2623TerazosinTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2623TerazosinTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2623TerazosinTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50268-764TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-764TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-764TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-764TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-765TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-765TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-765TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-765TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-766TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-766TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-766TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-766TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-767TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-767TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-767TerazosinTerazosin HydrochlorideAvPAKANDACurrent
50268-767TerazosinTerazosin HydrochlorideAvPAKANDACurrent
51655-675TERAZOSINterazosin hydrochlorideNorthwind Pharmaceuticals, LLCANDACurrent
51655-676TERAZOSINterazosin hydrochlorideNorthwind Pharmaceuticals, LLCANDACurrent
53002-1250TerazosinTerazosin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1250TerazosinTerazosin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1726TerazosinTerazosin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1726TerazosinTerazosin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1727TerazosinTerazosin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1727TerazosinTerazosin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1728TerazosinTerazosin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1728TerazosinTerazosin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53217-212TerazosinTerazosin HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
53808-0307Terazosin HydrochlorideTerazosin HydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0309Terazosin HydrochlorideTerazosin HydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0311Terazosin HydrochlorideTerazosin HydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-1056TerazosinTerazosin HydrochlorideState of Florida DOH Central PharmacyANDACurrent
55700-750TerazosinTerazosin HydrochlorideQuality Care Products, LLCANDACurrent
55700-750TerazosinTerazosin HydrochlorideQuality Care Products, LLCANDACurrent
59746-383TerazosinTerazosin HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-384TerazosinTerazosin HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-385TerazosinTerazosin HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-386TerazosinTerazosin HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
60760-316TerazosinTerazosin HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
63187-456TerazosinTerazosin HydrochlorideProficient Rx LPANDACurrent
63187-456TerazosinTerazosin HydrochlorideProficient Rx LPANDACurrent
63187-456TerazosinTerazosin HydrochlorideProficient Rx LPANDACurrent
63187-620TerazosinTerazosin HydrochlorideProficient Rx LPANDACurrent
63187-620TerazosinTerazosin HydrochlorideProficient Rx LPANDACurrent
63187-620TerazosinTerazosin HydrochlorideProficient Rx LPANDACurrent
63629-1414Terazosin HydrochlorideTerazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-1414Terazosin HydrochlorideTerazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2439TerazosinTerazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2439TerazosinTerazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-4525TERAZOSIN HYDROCHLORIDETerazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-4525TERAZOSIN HYDROCHLORIDETerazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-4525TERAZOSIN HYDROCHLORIDETerazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-5237TerazosinTerazosin HydrochlorideBryant Ranch PrepackANDACurrent
66267-325TerazosinTerazosin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-325TerazosinTerazosin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-325TerazosinTerazosin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-389TerazosinTerazosin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-389TerazosinTerazosin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent