Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 007936
Company: CHATTEM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELSUN SELENIUM SULFIDE 2.5% LOTION/SHAMPOO;TOPICAL Discontinued None Yes 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
05/17/1951 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
06/24/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/19/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/17/1988 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/23/1983 SUPPL-16 Labeling

Label is not available on this site.

09/15/1982 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/26/1983 SUPPL-14 Labeling

Label is not available on this site.

01/09/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1979 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/15/1979 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/19/1977 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/07/1977 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1977 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/29/1976 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1976 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

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