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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212520
Company: RVL PHARMS

Products on NDA 212520

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UPNEEQ	OXYMETAZOLINE HYDROCHLORIDE	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212520

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/08/2020	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/0212520s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212520Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212520Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/05/2021	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212520s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212520Orig1s004ltr.pdf
08/14/2020	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212520s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212520Orig1s001s002ltr.pdf

Labels for NDA 212520

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/05/2021	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212520s004lbl.pdf
08/14/2020	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212520s001s002lbl.pdf
07/08/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/0212520s000lbl.pdf

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