FDA.reportPublic FDA data

Application 022321

Type
NDA
Sponsor
ALPHARMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMBEDAMORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL20MG;0.8MGYesNo
002EMBEDAMORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MG;1.2MGYesNo
003EMBEDAMORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL50MG;2MGYesNo
004EMBEDAMORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL60MG;2.4MGYesNo
005EMBEDAMORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL80MG;3.2MGYesNo
006EMBEDAMORPHINE SULFATE; NALTREXONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL100MG;4MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60793-430EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-430EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-431EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-431EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-433EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-433EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-434EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-434EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-435EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-435EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-437EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent
60793-437EMBEDAMORPHINE SULFATE and NALTREXONE HYDROCHLORIDEPfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60386SUPPL2019-10-08
60385SUPPL2019-10-08
60366SUPPL2019-10-08
55689SUPPL2018-10-01
55688SUPPL2018-10-01
55637SUPPL2018-09-27
55636SUPPL2018-09-27
55635SUPPL2018-09-27
55634SUPPL2018-09-27
48582SUPPL2017-05-31
46339SUPPL2016-12-21
46332SUPPL2016-12-21
45467SUPPL2016-10-04
29594SUPPL2016-04-22
44495ORIG2015-11-04
29593SUPPL2015-07-06
43556SUPPL2014-10-17
29592SUPPL2014-10-17
17240SUPPL2014-10-17
7235SUPPL2014-08-20
7234SUPPL2014-04-17
17241SUPPL2014-04-16
17239SUPPL2013-11-05
29591SUPPL2013-06-04
17238SUPPL2013-06-03
7233SUPPL2013-04-18
17237SUPPL2012-07-12
44496ORIG2012-07-11
29590SUPPL2012-07-11
42492ORIG2010-05-25
7232ORIG2009-08-19
38573ORIG2009-08-18