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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202144
Company: ACTAVIS LABS FL INC

REMS

Products on ANDA 202144

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202144

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
12/15/2023	SUPPL-19	Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/04/2021	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
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.

Labels for ANDA 202144

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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