FDA.reportPublic FDA data

Application 075047

Type
ANDA
Sponsor
AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACEBUTOLOL HYDROCHLORIDEACEBUTOLOL HYDROCHLORIDECAPSULE;ORALEQ 200MG BASENoYes
002ACEBUTOLOL HYDROCHLORIDEACEBUTOLOL HYDROCHLORIDECAPSULE;ORALEQ 400MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-630Acebutolol HydrochlorideAcebutolol HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-630Acebutolol HydrochlorideAcebutolol HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-630Acebutolol HydrochlorideAcebutolol HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-631Acebutolol HydrochlorideAcebutolol HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-631Acebutolol HydrochlorideAcebutolol HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-631Acebutolol HydrochlorideAcebutolol HydrochlorideMarlex Pharmaceuticals IncANDACurrent
42291-101Acebutolol HydrochlorideAcebutolol HydrochlorideAvKARE, Inc.ANDACurrent
42291-101Acebutolol HydrochlorideAcebutolol HydrochlorideAvKARE, Inc.ANDACurrent
42291-102Acebutolol HydrochlorideAcebutolol HydrochlorideAvKARE, Inc.ANDACurrent
50268-050Acebutolol HydrochlorideAcebutolol HydrochlorideAvPAKANDACurrent
50268-050Acebutolol HydrochlorideAcebutolol HydrochlorideAvPAKANDACurrent
53746-669Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-669Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-669Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-669Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-670Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-670Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-670Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-670Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
65162-669Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-669Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-669Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-669Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-670Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-670Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-670Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-670Acebutolol HydrochlorideAcebutolol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22407ORIG2012-02-14
8499ORIG1999-12-30