Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016908
Company: CNTY LINE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDEX FLUOCINONIDE 0.05% CREAM;TOPICAL Discontinued None Yes No
LIDEX-E FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription AB2 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
06/30/1971 ORIG-1 Approval Type 1 - New Molecular Entity 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-58 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-55 Manufacturing (CMC)

Label is not available on this site.

01/27/1999 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1996 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

03/01/1995 SUPPL-52 Labeling

Label is not available on this site.

11/13/1992 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1992 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1995 SUPPL-49 Labeling

Label is not available on this site.

02/13/1990 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1989 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1989 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1984 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

09/07/1983 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/08/1983 SUPPL-43 Labeling

Label is not available on this site.

11/19/1982 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-40 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/20/1981 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/16/1981 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

01/19/1981 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/26/1981 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/18/1979 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1979 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/13/1979 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/23/1981 SUPPL-27 Labeling

Label is not available on this site.

11/29/1978 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1978 SUPPL-25 Labeling

Label is not available on this site.

10/12/1978 SUPPL-24 Labeling

Label is not available on this site.

09/12/1978 SUPPL-23 Labeling

Label is not available on this site.

07/05/1978 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/1978 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1977 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1977 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1977 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/04/1977 SUPPL-17 Labeling

Label is not available on this site.

05/06/1976 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1976 SUPPL-15

Label is not available on this site.

LIDEX

There are no Therapeutic Equivalents.

LIDEX-E

CREAM;TOPICAL; 0.05%
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE EMULSIFIED BASE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB2 074204 COSETTE
FLUOCINONIDE EMULSIFIED BASE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB2 076586 FOUGERA PHARMS
FLUOCINONIDE EMULSIFIED BASE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB2 072494 TARO PHARM INDS LTD
FLUOCINONIDE EMULSIFIED BASE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB2 072490 TEVA
LIDEX-E FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription Yes AB2 016908 CNTY LINE PHARMS

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