Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078309
Company: MYLAN SPECIALITY LP
Company: MYLAN SPECIALITY LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | SOLUTION;INHALATION | Prescription | AN | 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 |
---|---|---|---|---|---|---|---|
03/20/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/12/2023 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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09/25/2017 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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09/25/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
05/10/2013 | SUPPL-9 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
02/19/2013 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
LEVALBUTEROL HYDROCHLORIDE
SOLUTION;INHALATION; EQ 0.25% BASE
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | SOLUTION;INHALATION | Prescription | No | AN | 207628 | LUOXIN AUROVITAS |
LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | SOLUTION;INHALATION | Prescription | No | AN | 078309 | MYLAN SPECIALITY LP |
LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | SOLUTION;INHALATION | Prescription | No | AN | 200875 | TEVA PARENTERAL |
XOPENEX | LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | SOLUTION;INHALATION | Prescription | Yes | AN | 020837 | HIKMA |