Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017824
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOG HALCINONIDE 0.1% OINTMENT;TOPICAL Prescription None 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
06/15/1977 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
09/29/2004 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17824s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17824s024ltr.pdf
06/29/1990 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/27/1989 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/27/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/29/1985 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/13/1984 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1983 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/26/1981 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1982 SUPPL-13 Labeling

Label is not available on this site.

04/15/1980 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1980 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1979 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1978 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1978 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1978 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1977 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1977 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1977 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-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17824s024lbl.pdf

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