Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021012
Company: CIS BIO INTL SA
Company: CIS BIO INTL SA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEO TECT KIT | TECHNETIUM TC-99M DEPREOTIDE | N/A **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
08/03/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21012_Neotect_appltrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21012_Neotect.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/01/2004 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21012s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21012s007ltr.pdf | |
01/30/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/11/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/26/2001 | 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 |
---|---|---|---|---|---|
10/01/2004 | SUPPL-7 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21012s007lbl.pdf | |
08/03/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21012lbl.pdf |