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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009458
Company: IMPAX LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTISONE ACETATE CORTISONE ACETATE 25MG TABLET;ORAL 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
09/17/2001 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
10/06/1993 SUPPL-73 Labeling

Label is not available on this site.
10/03/1991 SUPPL-72 Labeling

Label is not available on this site.
09/17/2001 SUPPL-71 Labeling

Label is not available on this site.
04/07/1981 SUPPL-69 Labeling

Label is not available on this site.
05/21/1981 SUPPL-68 Labeling

Label is not available on this site.
10/29/1979 SUPPL-66 Labeling

Label is not available on this site.
08/21/1979 SUPPL-65 Labeling

Label is not available on this site.
09/17/2001 SUPPL-64 Labeling

Label is not available on this site.
08/21/1979 SUPPL-63 Labeling

Label is not available on this site.
08/21/1979 SUPPL-62 Labeling

Label is not available on this site.
08/21/1979 SUPPL-61 Labeling

Label is not available on this site.
08/21/1979 SUPPL-60 Labeling

Label is not available on this site.
10/30/1978 SUPPL-59 Labeling

Label is not available on this site.
09/17/2001 SUPPL-58 Labeling

Label is not available on this site.
05/03/1978 SUPPL-57 Labeling

Label is not available on this site.
06/07/1978 SUPPL-56 Labeling

Label is not available on this site.
06/07/1978 SUPPL-55 Labeling

Label is not available on this site.
01/09/1978 SUPPL-53 Labeling

Label is not available on this site.
01/09/1978 SUPPL-52 Labeling

Label is not available on this site.
01/09/1978 SUPPL-51 Labeling

Label is not available on this site.
01/09/1978 SUPPL-50 Labeling

Label is not available on this site.
02/23/1977 SUPPL-49 Labeling

Label is not available on this site.
02/23/1977 SUPPL-48 Labeling

Label is not available on this site.
02/23/1977 SUPPL-47 Labeling

Label is not available on this site.
02/23/1977 SUPPL-46 Labeling

Label is not available on this site.
02/23/1977 SUPPL-45 Labeling

Label is not available on this site.
02/23/1977 SUPPL-44 Labeling

Label is not available on this site.
02/23/1977 SUPPL-43 Labeling

Label is not available on this site.
02/23/1977 SUPPL-42 Labeling

Label is not available on this site.
02/23/1977 SUPPL-41 Labeling

Label is not available on this site.
02/23/1977 SUPPL-40 Labeling

Label is not available on this site.
02/23/1977 SUPPL-39 Labeling

Label is not available on this site.
02/23/1977 SUPPL-38 Labeling

Label is not available on this site.
09/17/2001 SUPPL-37 Labeling

Label is not available on this site.
09/17/2001 SUPPL-36 Labeling

Label is not available on this site.
09/17/2001 SUPPL-35 Labeling

Label is not available on this site.
09/17/2001 SUPPL-34 Labeling

Label is not available on this site.
09/17/2001 SUPPL-33 Labeling

Label is not available on this site.
09/17/2001 SUPPL-32 Labeling

Label is not available on this site.
09/17/2001 SUPPL-31 Labeling

Label is not available on this site.
09/17/2001 SUPPL-30 Labeling

Label is not available on this site.
09/17/2001 SUPPL-29 Labeling

Label is not available on this site.
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