Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205920
Company: ARMSTRONG PHARMS
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 |