Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021902
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VEREGEN | SINECATECHINS | 15% | 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 |
---|---|---|---|---|---|---|---|
10/31/2006 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021902lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021902s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021902s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/19/2018 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021902s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021902Orig1s033Ltr.pdf | |
07/08/2016 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/06/2015 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/09/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/2013 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/01/2013 | SUPPL-26 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021902Orig1s026ltr.pdf |
11/19/2012 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021902s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021902Orig1s025ltr.pdf | |
09/18/2008 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021902s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021902s017ltr.pdf | |
02/13/2008 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/27/2007 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/19/2007 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s002ltr.pdf | |
06/01/2007 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/19/2018 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021902s033lbl.pdf | |
11/19/2012 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021902s025lbl.pdf | |
09/18/2008 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021902s017lbl.pdf | |
12/19/2007 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s002lbl.pdf | |
06/01/2007 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s001lbl.pdf | |
10/31/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021902lbl.pdf |