FDA.reportPublic FDA data

Application 021217

Type
NDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXALGOHYDROMORPHONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL8MGYesNo
002EXALGOHYDROMORPHONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL12MGYesNo
003EXALGOHYDROMORPHONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL16MGYesNo
004EXALGOHYDROMORPHONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL32MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-3308Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3308Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3308Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3308Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3312Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3312Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3312Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3312Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3312Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3316Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3316Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3316Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3316Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3316Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3332Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3332Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3332Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3332Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3332Hydromorphone HydrochlorideHydromorphone HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
23635-408EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-408EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-408EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-408EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-412EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-412EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-412EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-412EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-416EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-416EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-416EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-416EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-432EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-432EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-432EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent
23635-432EXALGOHydromorphone HydrochlorideSpecGx LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60346SUPPL2019-10-08
60335SUPPL2019-10-08
60334SUPPL2019-10-08
55979SUPPL2018-10-17
55978SUPPL2018-10-17
55675SUPPL2018-10-01
55674SUPPL2018-10-01
48566SUPPL2017-05-30
46357SUPPL2016-12-21
46278SUPPL2016-12-20
45463SUPPL2016-10-04
27089SUPPL2016-04-22
4657SUPPL2015-07-02
14646SUPPL2015-06-04
4655SUPPL2015-06-04
4656SUPPL2014-08-20
14647SUPPL2014-06-26
27087SUPPL2014-06-19
27088SUPPL2014-04-17
36371SUPPL2014-04-16
4654SUPPL2013-04-17
4653SUPPL2013-03-19
36370SUPPL2013-03-18
27086SUPPL2012-08-28
14645SUPPL2012-08-28
36369SUPPL2012-07-12
44474ORIG2012-07-11
4652SUPPL2012-07-11
42033ORIG2010-05-23
24188ORIG2010-05-23
27085SUPPL2010-03-31
4651ORIG2010-03-03
36368ORIG2010-03-02