Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202408
Company: FERA PHARMS LLC

Products on NDA 202408

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVACLYR	ACYCLOVIR	3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202408

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2019	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/0202408s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202408Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/202408Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202408s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202408Orig1s001ltr.pdf

Labels for NDA 202408

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202408s001lbl.pdf
03/29/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/0202408s000lbl.pdf