Drugs@FDA: FDA-Approved Drugs
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 |