Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202144
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 12MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 16MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 32MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No 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
05/12/2014 ORIG-1 Approval Not Applicable Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202144Orig1s000lbl&MG.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202144Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-15 REMS - MODIFIED - D-N-A

Label is not available on this site.

11/07/2017 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/26/2017 SUPPL-13 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-10 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-8 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-7 REMS-Modified

Label is not available on this site.

06/30/2016 SUPPL-6 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202144s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202144Orig1s006ltr.pdf
08/19/2014 SUPPL-5 REMS-Modified

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/30/2016 SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202144s006lbl.pdf
05/12/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202144Orig1s000lbl&MG.pdf

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