Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021479
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZELAPAR | SELEGILINE HYDROCHLORIDE | 1.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | 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 |
---|---|---|---|---|---|---|---|
06/14/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021479lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021479s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021479_zelapar_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/16/2021 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021479s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021479Orig1s010ltr.pdf | |
08/19/2019 | SUPPL-8 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021479Orig1s008ltr.pdf |
10/09/2015 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/31/2014 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021479s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021479Orig1s005ltr.pdf | |
12/31/2008 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021479s003,021479s004ltr.pdf | |
12/31/2008 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021479s003,021479s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/16/2021 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021479s010lbl.pdf | |
07/31/2014 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021479s005lbl.pdf | |
12/31/2008 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf | |
12/31/2008 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf | |
06/14/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021479lbl.pdf |