Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 204200
Company: PAR STERILE PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADRENALIN EPINEPHRINE EQ 1MG BASE/ML (EQ 1MG BASE/ML) SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS Prescription 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
12/07/2012 ORIG-2 Approval Efficacy PRIORITY

Label is not available on this site.

12/07/2012 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204200s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204200Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204200_adrenalin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204200Orig1Orig2s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-7 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204200Orig1s007,204640Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204200Orig1s007,204640Orig1s008ltr.pdf
05/18/2016 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200s005,204640s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s005,204640Orig1s003ltr.pdf
09/12/2016 SUPPL-4 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s004ltr.pdf
03/03/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/31/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204200Orig1s007,204640Orig1s008lbl.pdf
09/12/2016 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200Orig1s004lbl.pdf
05/18/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200s005,204640s003lbl.pdf
12/07/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204200s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English