FDA.reportPublic FDA data

Application 021438

Type
NDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INNOPRAN XLPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL80MGYesNo
002INNOPRAN XLPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24090-450InnoPran XLpropranolol hydrochlorideAkrimax Pharmaceuticals, LLCNDACurrent
24090-451InnoPran XLpropranolol hydrochlorideAkrimax Pharmaceuticals, LLCNDACurrent
62559-590InnoPran XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-590InnoPran XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-590InnoPran XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-591InnoPran XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-591InnoPran XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-591InnoPran XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-600Inderal XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-600Inderal XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-600Inderal XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-601Inderal XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-601Inderal XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-601Inderal XLpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
76299-420INDERAL XLpropranolol hydrochlorideMist Pharmaceuticals, LLCNDACurrent
76299-422INDERAL XLpropranolol hydrochlorideMist Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77155SUPPL 2023-12-27
77134SUPPL 2023-12-27
68397SUPPL2021-08-18
68387SUPPL2021-08-17
36932SUPPL2013-11-22
27785SUPPL2013-11-20
27784SUPPL2010-12-21
5381SUPPL2010-12-21
36931SUPPL2010-12-16
15473SUPPL2010-12-16
15472SUPPL2010-01-12
5380SUPPL2010-01-05
5379SUPPL2008-01-09
36930SUPPL2008-01-08
5378SUPPL2004-10-29
36929ORIG2004-06-07
42166ORIG2003-07-08
27783ORIG2003-04-15