Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073045
Company: GENPHARM
Company: GENPHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALBUTEROL | ALBUTEROL | 0.09MG/INH | AEROSOL, METERED;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 |
---|---|---|---|---|---|---|---|
08/19/1997 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/073045_albuterol_toc.cfm |