Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020887
Company: CIS BIO INTL SA
Company: CIS BIO INTL SA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACUTECT | TECHNETIUM TC-99M APCITIDE | N/A | 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 |
---|---|---|---|---|---|---|---|
09/14/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20887lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20887ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20887.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/29/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/01/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/24/2001 | 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 |
---|---|---|---|---|---|
09/14/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20887lbl.pdf |