FDA.reportPublic FDA data

Application 075379

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALPROIC ACIDVALPROIC ACIDSYRUP;ORAL250MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-0675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-0675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-0675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-0675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-0675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-0675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-0675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-1350VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-1350VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-1350VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-1350VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-1350VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-1350VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-1350VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-1350VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-4675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-4675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-4675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-4675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-4675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-4675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-4675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0121-4675VALPROIC ACIDVALPROIC ACIDPharmaceutical Associates, Inc.ANDACurrent
0527-5407VALPROIC ACIDVALPROIC ACIDLannett Company, Inc.ANDACurrent
0527-5407VALPROIC ACIDVALPROIC ACIDLannett Company, Inc.ANDACurrent
17856-0675VALPROIC ACIDVALPROIC ACIDATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0675VALPROIC ACIDVALPROIC ACIDATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0675VALPROIC ACIDVALPROIC ACIDATLANTIC BIOLOGICALS CORP.ANDACurrent
55154-9430Valproic AcidVALPROIC ACIDCardinal HealthANDACurrent
70518-1968VALPROIC ACIDVALPROIC ACIDREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8639ORIG2000-12-15