Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017823
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOG HALCINONIDE 0.1% SOLUTION;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
05/04/1977 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-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17823s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17823s023ltr.pdf
10/08/1996 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1992 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/27/1989 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/30/1985 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1985 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1984 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/1984 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/1983 SUPPL-14 Labeling

Label is not available on this site.

12/30/1981 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/12/1980 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1980 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1980 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/18/1979 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1979 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1980 SUPPL-5 Labeling

Label is not available on this site.

05/12/1978 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1978 SUPPL-3 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-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17823s023lbl.pdf

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