Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 016909
Company: CNTY LINE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDEX FLUOCINONIDE 0.05% OINTMENT;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
09/22/1971 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
06/08/2016 SUPPL-53 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016909s053lbl.pdf
12/16/2005 SUPPL-49 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-47 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/16/1992 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1992 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1991 SUPPL-43 Labeling

Label is not available on this site.

02/13/1990 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1989 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1989 SUPPL-40 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/10/1989 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1984 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

05/16/1984 SUPPL-37 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/07/1983 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/21/1983 SUPPL-35 Labeling

Label is not available on this site.

11/19/1982 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/20/1981 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/10/1981 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1981 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/07/1980 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/24/1981 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1979 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/13/1979 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/07/1978 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/29/1978 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1979 SUPPL-20 Labeling

Label is not available on this site.

11/30/1978 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1978 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/1978 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/14/1977 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1977 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/11/1977 SUPPL-14 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/08/2016 SUPPL-53 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016909s053lbl.pdf

LIDEX

OINTMENT;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% OINTMENT;TOPICAL Prescription No AB 212976 CHEMO RESEARCH SL
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 074905 FOUGERA PHARMS
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 207538 NOVEL LABS INC
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 075008 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 207680 TELIGENT PHARMA INC
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 073481 TEVA
LIDEX FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription Yes AB 016909 CNTY LINE PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English