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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204785
Company: XSPIRE PHARMA

REMS

Products on ANDA 204785

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TREZIX	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	320.5MG;30MG;16MG	CAPSULE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204785

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2014	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204785Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204785Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/11/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/29/2019	SUPPL-7	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/29/2017	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/07/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 204785

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/26/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204785Orig1s000lbl.pdf

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