Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010831
Company: ORGANICS LAGRANGE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTICOTROPIN CORTICOTROPIN 40 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
CORTICOTROPIN CORTICOTROPIN 80 UNITS/ML 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
09/12/1957 ORIG-1 Approval Type 3 - New Dosage Form 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
07/14/1992 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1989 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

04/28/1988 SUPPL-52 Labeling

Label is not available on this site.

01/09/1985 SUPPL-51 Labeling

Label is not available on this site.

12/01/1980 SUPPL-49 Efficacy

Label is not available on this site.

12/01/1980 SUPPL-48 Efficacy

Label is not available on this site.

08/17/1977 SUPPL-43 Labeling

Label is not available on this site.

08/17/1977 SUPPL-42 Labeling

Label is not available on this site.

02/17/1978 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1977 SUPPL-39 Labeling

Label is not available on this site.

08/05/1976 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/29/1976 SUPPL-37 Labeling

Label is not available on this site.

06/29/1976 SUPPL-36 Labeling

Label is not available on this site.

05/03/1976 SUPPL-35 Labeling

Label is not available on this site.

12/31/1975 SUPPL-34 Labeling

Label is not available on this site.

12/31/1975 SUPPL-32 Labeling

Label is not available on this site.

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