Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019155
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAC-HYDRIN AMMONIUM LACTATE EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** LOTION;TOPICAL Discontinued None Yes No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
04/24/1985 ORIG-1 Approval Type 2 - New Active Ingredient 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
04/02/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/09/2007 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019155s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019155s022ltr.pdf
04/28/2004 SUPPL-20 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19155slr019,020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019155_S019 & S020_LAC_HYDRIN_LOTION_AP.pdf
04/28/2004 SUPPL-19 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19155slr019,020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019155_S019 & S020_LAC_HYDRIN_LOTION_AP.pdf
05/20/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/08/1997 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1997 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1995 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1995 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/19/1993 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/16/1992 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/19/1990 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1989 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1988 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1987 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/27/1986 SUPPL-3 Labeling

Label is not available on this site.

08/09/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/09/2007 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019155s022lbl.pdf

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