FDA.reportPublic FDA data

Application 078989

Type
ANDA
Sponsor
UNICHEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZALEPLONZALEPLONCAPSULE;ORAL5MGNoNo
002ZALEPLONZALEPLONCAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-131zaleplonzaleplonUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-131zaleplonzaleplonUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-131zaleplonzaleplonUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-131zaleplonzaleplonUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-132zaleplonzaleplonUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-132zaleplonzaleplonUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-132zaleplonzaleplonUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-132zaleplonzaleplonUnichem Pharmaceuticals (USA), Inc.ANDACurrent
33261-454zaleplonzaleplonAidarex Pharmaceuticals LLCANDACurrent
33261-486zaleplonzaleplonAidarex Pharmaceuticals LLCANDACurrent
35356-656zaleplonzaleplonLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
42254-130zaleplonzaleplonRebel Distributors CorpANDACurrent
42254-147zaleplonzaleplonRebel Distributors CorpANDACurrent
42254-189zaleplonzaleplonRebel Distributors CorpANDACurrent
43063-783zaleplonzaleplonPD-Rx Pharmaceuticals, InANDACurrent
43063-783zaleplonzaleplonPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-783zaleplonzaleplonPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-783zaleplonzaleplonPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-783zaleplonzaleplonPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-783zaleplonzaleplonPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-541zaleplonzaleplonmedsource pharmaceuticalsANDACurrent
45865-541zaleplonzaleplonmedsource pharmaceuticalsANDACurrent
50090-1564zaleplonzaleplonA-S Medication SolutionsANDACurrent
50090-1564zaleplonzaleplonA-S Medication SolutionsANDACurrent
50090-1564zaleplonzaleplonA-S Medication SolutionsANDACurrent
52959-957ZALEPLONZALEPLONH.J. Harkins Company, Inc.ANDACurrent
61919-629ZALEPLONZALEPLONDIRECT RXANDACurrent
63629-3405zaleplonzaleplonBryant Ranch PrepackANDACurrent
63629-3405zaleplonzaleplonBryant Ranch PrepackANDACurrent
63629-3405zaleplonzaleplonBryant Ranch PrepackANDACurrent
67877-210ZALEPLONZALEPLONAscend Laboratories, LLCANDACurrent
67877-211ZALEPLONZALEPLONAscend Laboratories, LLCANDACurrent
68788-6850zaleplonzaleplonPreferred Pharmaceuticals Inc.ANDACurrent
68788-7208zaleplonzaleplonPreferred Pharmaceuticals Inc.ANDACurrent
68788-7208zaleplonzaleplonPreferred Pharmaceuticals Inc.ANDACurrent
68788-7208zaleplonzaleplonPreferred Pharmaceuticals Inc.ANDACurrent
68788-7208zaleplonzaleplonPreferred Pharmaceuticals Inc.ANDACurrent
68788-7208zaleplonzaleplonPreferred Pharmaceuticals Inc.ANDACurrent
71335-0236zaleplonzaleplonBryant Ranch PrepackANDACurrent
71335-0236zaleplonzaleplonBryant Ranch PrepackANDACurrent
71335-0236zaleplonzaleplonBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44398ORIG2008-07-01
9210ORIG2008-06-10