Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016126
Company: WYETH CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRONITIN MIST EPINEPHRINE BITARTRATE 0.3MG/INH AEROSOL, METERED;INHALATION Discontinued None No No
PRIMATENE MIST EPINEPHRINE 0.2MG/INH AEROSOL, METERED;INHALATION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/08/1967 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/15/2004 SUPPL-29 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016126_S029_PRIMATENE MIST.pdf
01/13/2004 SUPPL-28 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016126_S028_PRIMATENE MIST.pdf
01/25/2002 SUPPL-27 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/016126_S027_PRIMATENE MIST.pdf
08/30/2001 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16126s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16126s25ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/016126_S025_PRIMATENE MIST.pdf
11/24/1999 SUPPL-24 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S024_PRIMATENE MIST.pdf
11/24/1999 SUPPL-23 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S023_PRIMATENE MIST.pdf
05/01/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/24/1999 SUPPL-20 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S020_PRIMATENE MIST.pdf
11/17/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/01/1999 SUPPL-17 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S017_PRIMATENE MIST.pdf
01/19/1996 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/09/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/24/1994 SUPPL-11 Labeling

Label is not available on this site.

03/24/1994 SUPPL-10 Labeling

Label is not available on this site.

03/24/1994 SUPPL-9 Labeling

Label is not available on this site.

04/22/1988 SUPPL-8 Labeling

Label is not available on this site.

05/19/1988 SUPPL-7 Labeling

Label is not available on this site.

10/03/1980 SUPPL-5 Labeling

Label is not available on this site.

05/25/1977 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/03/1980 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/30/2001 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16126s25lbl.pdf

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