Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016763
Company: MYLAN INSTITUTIONAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMYLON MAFENIDE ACETATE EQ 85MG BASE/GM CREAM;TOPICAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/24/1969 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2002 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

01/13/1999 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/14/1994 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/02/1994 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1990 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/23/1988 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1988 SUPPL-25 Labeling

Label is not available on this site.

12/11/1984 SUPPL-23 Labeling

Label is not available on this site.

08/24/1983 SUPPL-22 Labeling

Label is not available on this site.

11/03/1983 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/28/1981 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1980 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/1983 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/11/1977 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/28/1976 SUPPL-15 Labeling

Label is not available on this site.

01/26/1977 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

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