Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020001
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPEX FLUOCINOLONE ACETONIDE 0.01% SHAMPOO;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
08/27/1990 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
03/18/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/22/2016 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/17/2015 SUPPL-12 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020001Orig1s012ltr.pdf
07/06/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/12/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/26/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/30/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-5 Labeling

Label is not available on this site.

11/19/1991 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/24/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/19/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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