Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207916
Company: ARBOR PHARMS LLC

Products on NDA 207916

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CETYLEV	ACETYLCYSTEINE	500MG	TABLET, EFFERVESCENT;ORAL	Discontinued	None	Yes	No
CETYLEV	ACETYLCYSTEINE	2.5GM	TABLET, EFFERVESCENT;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207916

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2016	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207916s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207916Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207916_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2018	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
04/18/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207916s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207916Orig1s003ltr.pdf
07/20/2017	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 207916

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207916s003lbl.pdf
01/29/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207916s000lbl.pdf