Drugs@FDA: FDA-Approved Drugs
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LAC-HYDRIN | AMMONIUM LACTATE | EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION;TOPICAL | Discontinued | None | Yes | No |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. |
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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. |
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12/08/1997 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/08/1997 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/08/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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. |
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02/19/1993 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/16/1992 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/26/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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11/19/1990 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/15/1989 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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. |
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03/27/1986 | SUPPL-3 | Labeling |
Label is not available on this site. |
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08/09/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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 |