Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020001
Company: GALDERMA LABS LP

Products on NDA 020001

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020001

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.