Drugs@FDA: FDA Approved Drug Products

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

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

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