Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018234
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOG-E HALCINONIDE 0.1% CREAM;TOPICAL Discontinued None 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
01/24/1980 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
09/29/2004 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18234s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18234s020ltr.pdf
07/17/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/27/1989 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1988 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/24/1986 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/27/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/11/1986 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/29/1985 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/16/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/03/1984 SUPPL-9 Labeling

Label is not available on this site.

08/19/1983 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/05/1983 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/13/1982 SUPPL-6 Labeling

Label is not available on this site.

06/22/1981 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1980 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1980 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/15/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1980 SUPPL-1 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
09/29/2004 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18234s020lbl.pdf

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