Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008317
Company: PARKEDALE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTH CORTICOTROPIN 25 UNITS/VIAL INJECTABLE;INJECTION Discontinued None No No
ACTH CORTICOTROPIN 40 UNITS/VIAL INJECTABLE;INJECTION 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
03/14/1952 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
07/25/1996 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1990 SUPPL-15 Labeling

Label is not available on this site.

01/19/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/23/1989 SUPPL-13 Labeling

Label is not available on this site.

12/01/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/08/1980 SUPPL-9 Labeling

Label is not available on this site.

03/30/1978 SUPPL-8 Labeling

Label is not available on this site.

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