Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011483
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNALGOS-DC ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE 356.4MG;30MG;16MG CAPSULE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/07/1958 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011483Orig1s031s032ltr.pdf
09/18/2018 SUPPL-31 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011483Orig1s031s032ltr.pdf
08/29/2017 SUPPL-30 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011483Orig1s030ltr.pdf
12/16/2016 SUPPL-29 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011483s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011483Orig1s029ltr.pdf
05/09/2013 SUPPL-27 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011483s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/011483Orig1s027ltr.pdf
05/11/2006 SUPPL-23 Labeling-Container/Carton Labels

Label is not available on this site.

03/13/2006 SUPPL-22 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/31/2001 SUPPL-15 Labeling

Label is not available on this site.

08/05/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/03/1987 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/06/1983 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/06/1983 SUPPL-11 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2018 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf
09/18/2018 SUPPL-31 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf
08/29/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.pdf
08/29/2017 SUPPL-30 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.pdf
12/16/2016 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011483s029lbl.pdf
12/16/2016 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011483s029lbl.pdf
12/16/2016 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011483s029lbl.pdf
05/09/2013 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011483s027lbl.pdf
05/09/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011483s027lbl.pdf

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