Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017373
Company: CNTY LINE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% GEL;TOPICAL Prescription AB 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
05/15/1973 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
12/16/2005 SUPPL-38 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016908s058,016909s049,017373s038,018849s018ltr.pdf
09/26/2000 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/16/1992 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1992 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1991 SUPPL-31 Labeling

Label is not available on this site.

02/13/1990 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1989 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1989 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1985 SUPPL-27 Labeling

Label is not available on this site.

08/29/1984 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/07/1983 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/06/1983 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/21/1983 SUPPL-23 Labeling

Label is not available on this site.

11/19/1982 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/20/1981 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/10/1981 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1981 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1981 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/07/1980 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1979 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/13/1979 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/29/1978 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1978 SUPPL-10 Labeling

Label is not available on this site.

10/13/1978 SUPPL-9 Labeling

Label is not available on this site.

07/05/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1977 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1977 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/04/1977 SUPPL-5 Labeling

Label is not available on this site.

01/23/1976 SUPPL-4 Labeling

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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