Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207628
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
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 |
---|---|---|---|---|---|---|---|
01/31/2017 | 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 |
---|---|---|---|---|---|
02/07/2020 | SUPPL-4 | 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 | AUROBINDO PHARMA LTD |
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 | AKORN |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English