Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074945
Company: WATSON PHARMS TEVA
Company: WATSON PHARMS TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATRACURIUM BESYLATE | ATRACURIUM BESYLATE | 10MG/ML | 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 |
---|---|---|---|---|---|---|---|
07/28/1998 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74945ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074945_atracurium_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/26/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
04/28/2000 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |