FDA.reportPublic FDA data

Application 071173

Type
ANDA
Sponsor
INNOGENIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALOPERIDOLHALOPERIDOLTABLET;ORAL10MGNoNo
002HALOPERIDOLHALOPERIDOLTABLET;ORAL0.5MGNoNo
003HALOPERIDOLHALOPERIDOLTABLET;ORAL1MGNoNo
004HALOPERIDOLHALOPERIDOLTABLET;ORAL2MGNoNo
005HALOPERIDOLHALOPERIDOLTABLET;ORAL5MGNoNo
006HALOPERIDOLHALOPERIDOLTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7240HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-7241HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-7242HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
10135-752HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-753HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-754HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-755HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-756HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-757HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
17856-0730HaloperidolHaloperidolATLANTIC BIOLOGICALS CORP.ANDACurrent
50090-5989HaloperidolHaloperidolA-S Medication SolutionsANDACurrent
58657-700HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-700HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-701HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-701HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-702HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-702HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-703HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-703HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-704HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-704HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-705HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-705HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
63629-2326HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-2326HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9270HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9271HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9272HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9273HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9274HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9275HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
69292-580HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
69292-582HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
69292-584HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
69292-586HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
69292-588HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
69292-590HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
70518-2680HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2680HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2680HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2680HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2682HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2682HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2682HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2682HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2687HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2687HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2687HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2687HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3021HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3437HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3437HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3440HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3500HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3587HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3608HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
71247-150HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-150HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-151HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-151HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-152HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-152HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-153HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-153HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-154HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-154HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-155HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-155HaloperidolHaloperidolInnogenix, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53954ORIG2018-05-01