FDA.reportPublic FDA data

Application 076071

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LISINOPRILLISINOPRILTABLET;ORAL2.5MGNoNo
002LISINOPRILLISINOPRILTABLET;ORAL5MGNoNo
003LISINOPRILLISINOPRILTABLET;ORAL10MGNoNo
004LISINOPRILLISINOPRILTABLET;ORAL20MGNoNo
005LISINOPRILLISINOPRILTABLET;ORAL30MGNoNo
006LISINOPRILLISINOPRILTABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2072LisinoprillisinoprilMylan Pharmaceuticals Inc.ANDACurrent
0378-2073LisinoprillisinoprilMylan Pharmaceuticals Inc.ANDACurrent
0378-2074LisinoprillisinoprilMylan Pharmaceuticals Inc.ANDACurrent
0378-2075LisinoprillisinoprilMylan Pharmaceuticals Inc.ANDACurrent
0378-2076LisinoprillisinoprilMylan Pharmaceuticals Inc.ANDACurrent
0378-2077LisinoprillisinoprilMylan Pharmaceuticals Inc.ANDACurrent
43353-071LisinoprillisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-121LisinoprillisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-168LisinoprillisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-169LisinoprillisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-179LisinoprillisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-3388LisinoprillisinoprilA-S Medication SolutionsANDACurrent
51079-981LisinoprillisinoprilMylan Institutional Inc.ANDACurrent
51079-982LisinoprillisinoprilMylan Institutional Inc.ANDACurrent
51079-983LisinoprillisinoprilMylan Institutional Inc.ANDACurrent
53808-0104LisinoprillisinoprilState of Florida DOH Central PharmacyANDACurrent
53808-0702LisinoprillisinoprilState of Florida DOH Central PharmacyANDACurrent
55154-5051LisinoprillisinoprilCardinal HealthANDACurrent
55154-5051LisinoprillisinoprilCardinal HealthANDACurrent
55154-5052LisinoprillisinoprilCardinal HealthANDACurrent
55154-5052LisinoprillisinoprilCardinal HealthANDACurrent
55154-5053LisinoprillisinoprilCardinal HealthANDACurrent
55154-5053LisinoprillisinoprilCardinal HealthANDACurrent
55154-5082LisinoprillisinoprilCardinal HealthANDACurrent
55154-5082LisinoprillisinoprilCardinal HealthANDACurrent
60429-206LisinoprillisinoprilGolden State Medical Supply Inc.ANDACurrent
60429-207LisinoprillisinoprilGolden State Medical Supply Inc.ANDACurrent
60429-208LisinoprillisinoprilGolden State Medical Supply Inc.ANDACurrent
60429-209LisinoprillisinoprilGolden State Medical Supply Inc.ANDACurrent
60429-211LisinoprillisinoprilGolden State Medical Supply Inc.ANDACurrent
60429-212LisinoprillisinoprilGolden State Medical Supply Inc.ANDACurrent
70518-0402LisinoprillisinoprilREMEDYREPACK INC.ANDACurrent
70518-0575LisinoprillisinoprilREMEDYREPACK INC.ANDACurrent
70518-0575LisinoprillisinoprilREMEDYREPACK INC.ANDACurrent
70518-0726LisinoprillisinoprilREMEDYREPACK INC.ANDACurrent
70518-0726LisinoprillisinoprilREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8861ORIG2004-06-24