← FDA DRUG APPROVALS

FDA NDA · NDA016126

BRONITIN MIST

Sponsor: WYETH CONS

APPLICATION
NDA016126
TYPE
NDA
ORIGINAL APPROVAL
1967-11-08
LATEST ACTION
2004-01-15
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued

Products

BRONITIN MISTDiscontinued
EPINEPHRINE BITARTRATE 0.3MG/INH · AEROSOL, METERED · INHALATION
PRIMATENE MISTDiscontinued
EPINEPHRINE 0.2MG/INH · AEROSOL, METERED · INHALATION

Approval history

2004-01-15Supplement · Supplement 29 · standard — Review ↗AP
2004-01-13Supplement · Supplement 28 · standard — Review ↗AP
2002-01-25Manufacturing (CMC) · Supplement 27 · standard — Review ↗AP
2001-08-30Labeling · Supplement 25 · standard — Review ↗AP
1999-12-01Manufacturing (CMC) · Supplement 17 · standard — Review ↗AP
1999-11-24Manufacturing (CMC) · Supplement 23 · standard — Review ↗AP
1999-11-24Manufacturing (CMC) · Supplement 24 · standard — Review ↗AP
1999-11-24Manufacturing (CMC) · Supplement 20 · standard — Review ↗AP
1998-05-01Manufacturing (CMC) · Supplement 21 · standardAP
1996-01-19Manufacturing (CMC) · Supplement 16 · standardAP
1995-11-17Manufacturing (CMC) · Supplement 18 · standardAP
1994-03-24Labeling · Supplement 9AP
1994-03-24Labeling · Supplement 11AP
1994-03-24Labeling · Supplement 10AP
1993-10-22Manufacturing (CMC) · Supplement 13 · standardAP
1991-08-09Manufacturing (CMC) · Supplement 12 · standardAP
1988-05-19Labeling · Supplement 7AP
1988-04-22Labeling · Supplement 8AP
1980-10-03Labeling · Supplement 5AP
1980-10-03Labeling · Supplement 3AP
1977-05-25Manufacturing (CMC) · Supplement 4 · standardAP
1967-11-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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