FDA.reportPublic FDA data

Application 075417

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOZAPINECLOZAPINETABLET;ORAL25MGNoNo
002CLOZAPINECLOZAPINETABLET;ORAL100MGNoNo
003CLOZAPINECLOZAPINETABLET;ORAL12.5MGNoNo
004CLOZAPINECLOZAPINETABLET;ORAL50MGNoNo
005CLOZAPINECLOZAPINETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0825ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0825ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0825ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0825ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0825ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0825ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0825ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0825ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0860ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0860ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0860ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0860ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0860ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0860ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0860ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0860ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0972ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0972ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0972ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0972ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0972ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0972ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0972ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0972ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0973ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0973ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0973ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0973ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0973ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0973ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0973ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
0378-0973ClozapineclozapineMylan Pharmaceuticals Inc.ANDACurrent
51079-749ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-749ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-749ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-749ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-921ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-921ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-921ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-921ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-922ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-922ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-922ClozapineclozapineMylan Institutional Inc.ANDACurrent
51079-922ClozapineclozapineMylan Institutional Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44526ORIG2015-09-16
30878SUPPL2010-04-28
8662SUPPL2010-04-28
8661SUPPL2010-04-28
42993ORIG2003-08-04
30877ORIG1999-05-27