Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091607
Company: SUN PHARM

• REMS

Products on ANDA 091607

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	No	Yes
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091607

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/2011	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091607Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/091607Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-31	Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-29	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/10/2021	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/21/2018	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-14	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/29/2017	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/29/2017	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/21/2017	SUPPL-10	Labeling		Label is not available on this site.
12/16/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-7	Labeling-Package Insert		Label is not available on this site.