FDA.reportPublic FDA data

Application 021011

Type
NDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROXICODONEOXYCODONE HYDROCHLORIDETABLET;ORAL15MGYesYes
002ROXICODONEOXYCODONE HYDROCHLORIDETABLET;ORAL30MGYesNo
003ROXICODONEOXYCODONE HYDROCHLORIDETABLET;ORAL5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23635-580Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-580Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-580Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-580Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-581Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-581Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-581Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-581Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-581Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-581Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-582Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-582Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-582Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-582Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-582Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent
23635-582Roxicodoneoxycodone hydrochlorideSpecGx LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84673SUPPL 2026-01-06
84566SUPPL 2025-12-29
80092SUPPL 2024-11-04
78215SUPPL 2024-04-23
78214SUPPL 2024-04-23
78185SUPPL 2024-04-22
76999SUPPL 2023-12-19
76901SUPPL 2023-12-18
76231ORIG 2023-11-03
66591SUPPL2021-03-08
66590SUPPL2021-03-08
66547SUPPL2021-03-05
60344SUPPL2019-10-08
60331SUPPL2019-10-08
60330SUPPL2019-10-08
55905SUPPL2018-10-12
55904SUPPL2018-10-12
55663SUPPL2018-09-28
55662SUPPL2018-09-28
46363SUPPL2016-12-21
46269SUPPL2016-12-20
14159SUPPL2009-06-07
26481SUPPL2009-05-20
35879SUPPL2009-02-24
26480SUPPL2009-02-24
41874ORIG2004-03-10
14158ORIG2000-08-31
4032ORIG2000-08-31