FDA.reportPublic FDA data

Application 022195

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL10MG/5MLYesNo
002MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL20MG/5MLYesNo
003MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL100MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0237Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0237Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0237Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0237Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0237Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0237Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0238Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0238Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0238Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0238Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0238Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0238Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0404Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0404Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0404Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0404Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0404Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0517Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0517Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0517Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0517Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0054-0517Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.NDACurrent
0121-0904Morphine SulfateMorphine SulfatePharmaceutical Associates, Inc.NDACurrent
0121-0904Morphine SulfateMorphine SulfatePharmaceutical Associates, Inc.NDACurrent
0121-0904Morphine SulfateMorphine SulfatePharmaceutical Associates, Inc.NDACurrent
17856-0237Morphine SulfateMorphine SulfateAtlantic Biologicals CorpsNDACurrent
17856-0237Morphine SulfateMorphine SulfateATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0238Morphine SulfateMorphine SulfateATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0238Morphine SulfateMorphine SulfateAtlantic Biologicals CorpsNDACurrent
17856-0403Morphine SulfateMorphine SulfateATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0406Morphine SulfateMorphine SulfateATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0517Morphine SulfateMorphine SulfateATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0517Morphine SulfateMorphine SulfateATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0517Morphine SulfateMorphine SulfateATLANTIC BIOLOGICALS CORP.NDACurrent
49999-849Morphine SulfateMorphine SulfateLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
49999-849Morphine SulfateMorphine SulfateLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
49999-849Morphine SulfateMorphine SulfateLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
52959-138Morphine SulfateMorphine SulfateH.J. Harkins Company, Inc.NDACurrent
52959-182Morphine SulfateMorphine SulfateH.J. Harkins Company, Inc.NDACurrent
68094-001Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent
68094-001Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent
68094-001Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent
68094-001Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent
68094-001Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent
68094-045Morphine SulfateMorphine SulfatePrecision Dose, Inc.NDACurrent
68094-045Morphine SulfateMorphine SulfatePrecision Dose, Inc.NDACurrent
68094-056Morphine SulfateMorphine SulfatePrecision Dose, Inc.NDACurrent
68094-754Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent
68094-754Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent
68094-754Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent
68094-754Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent
68094-755Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent
68094-755Morphine SulfateMorphine SulfatePrecision Dose Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84690SUPPL 2026-01-06
84607SUPPL 2025-12-31
80072SUPPL 2024-11-04
77007SUPPL 2023-12-19
76924SUPPL 2023-12-18
76921SUPPL 2023-12-18
76235ORIG 2023-11-03
68177SUPPL2021-07-26
68167SUPPL2021-07-23
67692SUPPL2021-06-03
67690SUPPL2021-06-03
67689SUPPL2021-06-03
66601SUPPL2021-03-08
66600SUPPL2021-03-08
66555SUPPL2021-03-05
60375SUPPL2019-10-08
60374SUPPL2019-10-08
60362SUPPL2019-10-08
55995SUPPL2018-10-17
55994SUPPL2018-10-17
55695SUPPL2018-10-01
55694SUPPL2018-10-01
46347SUPPL2016-12-21
46295SUPPL2016-12-20
38366SUPPL2015-04-23
29386SUPPL2015-04-22
7027SUPPL2014-01-14
7026SUPPL2012-01-25
17067SUPPL2012-01-23
7025SUPPL2011-10-20
38365SUPPL2010-01-29
7024SUPPL2010-01-29
24256ORIG2009-04-01
21956ORIG2009-04-01
17066ORIG2008-03-24
29385ORIG2008-03-19