Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018663
Company: CHART MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHYMODIACTIN CHYMOPAPAIN 10,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CHYMODIACTIN CHYMOPAPAIN 4,000 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
11/10/1982 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/1994 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1994 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1994 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1993 SUPPL-25 Labeling

Label is not available on this site.

10/02/1991 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/28/1993 SUPPL-23 Labeling

Label is not available on this site.

11/28/1989 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/15/1986 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1987 SUPPL-18 Labeling

Label is not available on this site.

07/18/1986 SUPPL-17 Labeling

Label is not available on this site.

07/01/1987 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1985 SUPPL-15 Labeling

Label is not available on this site.

08/21/1984 SUPPL-12 Labeling

Label is not available on this site.

08/21/1984 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1984 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1984 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1984 SUPPL-5 Labeling

Label is not available on this site.

07/09/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1984 SUPPL-2 Labeling

Label is not available on this site.

07/09/1984 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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