Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205920
Company: ARMSTRONG PHARMS

Products on NDA 205920

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRIMATENE MIST	EPINEPHRINE	0.125MG/INH	AEROSOL, METERED;INHALATION	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205920

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205920Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205920Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/205920Orig1s000TOC.cfm

Labels for NDA 205920

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205920Orig1s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

PRIMATENE MIST

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

AEROSOL, METERED;INHALATION; 0.125MG/INH

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
PRIMATENE MIST	EPINEPHRINE	0.125MG/INH	AEROSOL, METERED;INHALATION	Over-the-counter	Yes	205920	ARMSTRONG PHARMS