FDA.reportPublic FDA data

Application 213709

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL1.25MG;1.25MG;1.25MG;1.25MGNoNo
002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL1.875MG;1.875MG;1.875MG;1.875MGNoNo
003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL2.5MG;2.5MG;2.5MG;2.5MGNoNo
004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL3.125MG;3.125MG;3.125MG;3.125MGNoNo
005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL3.75MG;3.75MG;3.75MG;3.75MGNoNo
006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL5MG;5MG;5MG;5MGNoNo
007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL7.5MG;7.5MG;7.5MG;7.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-155DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-155DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-156DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-156DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-157DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-157DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-158DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-158DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-159DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-159DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-163DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-163DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-164DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
31722-164DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateCamber Pharmaceuticals, Inc.ANDACurrent
43602-370DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, IncANDACurrent
43602-371DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, IncANDACurrent
43602-372DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, IncANDACurrent
43602-373DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, IncANDACurrent
43602-374DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, IncANDACurrent
43602-375DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, IncANDACurrent
43602-376DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, IncANDACurrent
43602-982DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, Inc.ANDACurrent
43602-983DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, Inc.ANDACurrent
43602-984DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, Inc.ANDACurrent
43602-985DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, Inc.ANDACurrent
43602-986DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, Inc.ANDACurrent
43602-987DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, Inc.ANDACurrent
43602-988DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAscent Pharmaceuticals, Inc.ANDACurrent
60687-644DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEdextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateAmerican Health PackagingANDACurrent