FDA.reportPublic FDA data

Application 017116

Type
NDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002METHADOSEMETHADONE HYDROCHLORIDECONCENTRATE;ORAL10MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-0527METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-0527METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-0527METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-0527METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-0527METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-0527METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-8725METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-8725METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-8725METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-8725METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-8725METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
0406-8725METHADOSEmethadone hydrochlorideSpecGx LLCNDACurrent
17856-0526METHADOSEmethadone hydrochlorideATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0526METHADOSEmethadone hydrochlorideATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0527METHADOSEmethadone hydrochlorideAtlantic Biologicals CorpsNDACurrent
17856-0527METHADOSEmethadone hydrochlorideAtlantic Biologicals CorpsNDACurrent
17856-0527METHADOSEmethadone hydrochlorideATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0527METHADOSEmethadone hydrochlorideATLANTIC BIOLOGICALS CORP.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84705SUPPL 2026-01-07
84554SUPPL 2025-12-29
77026SUPPL 2023-12-19
76948SUPPL 2023-12-18
69522SUPPL2021-12-09
68672SUPPL2021-09-21
68595SUPPL2021-09-13
67683SUPPL2021-06-03
67679SUPPL2021-06-03
60339SUPPL2019-10-08
60288SUPPL2019-10-08
52284SUPPL2018-02-02
52251SUPPL2018-02-01
46212SUPPL2017-01-03
46405SUPPL2016-12-21
33233SUPPL2008-02-14
13097SUPPL2008-02-07
23536ORIG2006-11-27
13096SUPPL2005-08-08
13095SUPPL2005-08-08
33232SUPPL2005-05-27
13094SUPPL2005-05-27
10971SUPPL2005-05-27
556SUPPL2005-05-27
13093SUPPL2002-03-27