FDA.reportPublic FDA data

Application 071297

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDETABLET;ORALEQ 25MG BASE;10MGNoYes
002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDETABLET;ORALEQ 12.5MG BASE;5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18345SUPPL2014-09-05
39430SUPPL2014-07-30
23427SUPPL2014-07-30
18344SUPPL2014-07-30
30667SUPPL2014-07-24
8406SUPPL2014-07-24