Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074944
Company: WATSON LABS INC
Company: WATSON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATRACURIUM BESYLATE PRESERVATIVE FREE | 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/1998/74944ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074944_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. |