FDA.reportPublic FDA data

Application 077560

Type
ANDA
Sponsor
LUPIN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASENoNo
002ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASENoNo
003ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 60MG BASENoNo
004ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 80MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-169Ziprasidone HydrochlorideZiprasidone HydrochlorideRebel Distributors CorpANDACurrent
42254-170Ziprasidone HydrochlorideZiprasidone HydrochlorideRebel Distributors CorpANDACurrent
42254-171Ziprasidone HydrochlorideZiprasidone HydrochlorideRebel Distributors CorpANDACurrent
42254-172Ziprasidone HydrochlorideZiprasidone HydrochlorideRebel Distributors CorpANDACurrent
50436-0331Ziprasidone HydrochlorideZiprasidone HydrochlorideUnit Dose ServicesANDACurrent
57297-331Ziprasidone HydrochlorideZiprasidone HydrochlorideLUPIN LIMITEDANDACurrent
57297-332Ziprasidone HydrochlorideZiprasidone HydrochlorideLUPIN LIMITEDANDACurrent
57297-333Ziprasidone HydrochlorideZiprasidone HydrochlorideLUPIN LIMITEDANDACurrent
57297-334Ziprasidone HydrochlorideZiprasidone HydrochlorideLUPIN LIMITEDANDACurrent
68001-136Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-136Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-136Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-137Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-137Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-137Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-138Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-138Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-138Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-139Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-139Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68001-139Ziprasidone HydrochlorideZiprasidone HydrochlorideBluePoint LaboratoriesANDACurrent
68180-331Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-331Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-331Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-331Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-331Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-331Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-332Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-332Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-332Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-332Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-332Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-332Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-333Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-333Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-333Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-333Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-333Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-333Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-334Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-334Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-334Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-334Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-334Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-334Ziprasidone HydrochlorideZiprasidone HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
70518-1716Ziprasidone HydrochlorideZiprasidone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1716Ziprasidone HydrochlorideZiprasidone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2622Ziprasidone HydrochlorideZiprasidone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2622Ziprasidone HydrochlorideZiprasidone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2622Ziprasidone HydrochlorideZiprasidone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2622Ziprasidone HydrochlorideZiprasidone HydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31262ORIG2007-05-29