Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075394
Company: WOCKHARDT EU OPERATN
Company: WOCKHARDT EU OPERATN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 11/22/1999 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75394ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/076394_amiodarone-hydrochloride_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/15/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/2001 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/30/2001 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/30/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |