Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072537
Company: ACP NIMBLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription AB 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
02/07/1989 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/23/2017 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

08/30/2001 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

02/26/2001 SUPPL-16 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/17/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/27/1997 SUPPL-14 Labeling

Label is not available on this site.

08/08/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/08/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/08/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/13/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/17/1996 SUPPL-9 Labeling

Label is not available on this site.

04/09/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/30/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/01/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FLUOCINONIDE

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription No AB 072537 ACP NIMBLE
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription Yes AB 017373 CNTY LINE PHARMS
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription No AB 072933 FOUGERA PHARMS INC
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription No AB 074935 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription No AB 209030 TELIGENT PHARMA INC

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