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FDA NDA · NDA009458

CORTISONE ACETATE

Sponsor: IMPAX LABS

APPLICATION
NDA009458
TYPE
NDA
ORIGINAL APPROVAL
2001-09-17
LATEST ACTION
2001-09-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CORTISONE ACETATEDiscontinued
CORTISONE ACETATE 25MG · TABLET · ORAL

Approval history

2001-09-17Labeling · Supplement 29AP
2001-09-17Labeling · Supplement 35AP
2001-09-17Labeling · Supplement 33AP
2001-09-17Labeling · Supplement 31AP
2001-09-17Type 5 - New Formulation or New Manufacturer · Original · standardAP
2001-09-17Labeling · Supplement 58AP
2001-09-17Labeling · Supplement 64AP
2001-09-17Labeling · Supplement 36AP
2001-09-17Labeling · Supplement 34AP
2001-09-17Labeling · Supplement 32AP
2001-09-17Labeling · Supplement 30AP
2001-09-17Labeling · Supplement 71AP
2001-09-17Labeling · Supplement 37AP
1993-10-06Labeling · Supplement 73AP
1991-10-03Labeling · Supplement 72AP
1981-05-21Labeling · Supplement 68AP
1981-04-07Labeling · Supplement 69AP
1979-10-29Labeling · Supplement 66AP
1979-08-21Labeling · Supplement 62AP
1979-08-21Labeling · Supplement 60AP
1979-08-21Labeling · Supplement 65AP
1979-08-21Labeling · Supplement 63AP
1979-08-21Labeling · Supplement 61AP
1978-10-30Labeling · Supplement 59AP
1978-06-07Labeling · Supplement 56AP
1978-06-07Labeling · Supplement 55AP
1978-05-03Labeling · Supplement 57AP
1978-01-09Labeling · Supplement 52AP
1978-01-09Labeling · Supplement 50AP
1978-01-09Labeling · Supplement 53AP
1978-01-09Labeling · Supplement 51AP
1977-02-23Labeling · Supplement 43AP
1977-02-23Labeling · Supplement 41AP
1977-02-23Labeling · Supplement 48AP
1977-02-23Labeling · Supplement 46AP
1977-02-23Labeling · Supplement 38AP
1977-02-23Labeling · Supplement 44AP
1977-02-23Labeling · Supplement 42AP
1977-02-23Labeling · Supplement 40AP
1977-02-23Labeling · Supplement 49AP
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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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