Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207820
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION;INHALATION | Discontinued | None | No | No |
| LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION;INHALATION | Discontinued | None | No | No |
| LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% 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 |
|---|---|---|---|---|---|---|---|
| 11/05/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2019 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |