Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017556
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOG HALCINONIDE 0.1% CREAM;TOPICAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/1974 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
04/02/2014 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/10/2009 SUPPL-38 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017556s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017556s038ltr.pdf
09/29/2004 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17556s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17556s034ltr.pdf
06/29/1990 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/27/1989 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1989 SUPPL-31 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/03/1987 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/27/1986 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/22/1986 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/30/1985 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1985 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/24/1984 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1982 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/26/1982 SUPPL-23 Labeling

Label is not available on this site.

05/20/1980 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/24/1980 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1980 SUPPL-19 Labeling

Label is not available on this site.

02/02/1979 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/10/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1978 SUPPL-16 Labeling

Label is not available on this site.

06/07/1978 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1978 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/09/1978 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1977 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1977 SUPPL-8 Labeling

Label is not available on this site.

02/09/1976 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1975 SUPPL-4 Labeling

Label is not available on this site.

05/07/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/10/2009 SUPPL-38 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017556s038lbl.pdf
06/10/2009 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017556s038lbl.pdf
09/29/2004 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17556s034lbl.pdf

HALOG

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALCINONIDE HALCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 211027 MYLAN
HALOG HALCINONIDE 0.1% CREAM;TOPICAL Prescription Yes AB 017556 SUN PHARM INDS INC

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