Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020508
Company: SUN PHARM INDS INC
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LAC-HYDRIN | AMMONIUM LACTATE | EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
08/29/1996 | 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 |
---|---|---|---|---|---|
12/13/2004 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20508s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20508s006ltr.pdf | |
08/25/2000 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20508S5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20508S5ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20508S005_Lac-Hydrin.cfm | |
07/19/1999 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/13/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/21/1998 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/13/2004 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20508s006lbl.pdf | |
08/25/2000 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20508S5lbl.pdf |