Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075664
Company: NEPHRON
Company: NEPHRON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.5% BASE | SOLUTION;INHALATION | Prescription | AN | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/26/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75664ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075664.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/29/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
ALBUTEROL SULFATE
SOLUTION;INHALATION; EQ 0.5% BASE
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.5% BASE | SOLUTION;INHALATION | Prescription | No | AN | 075664 | NEPHRON |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.5% BASE | SOLUTION;INHALATION | Prescription | No | AN | 074543 | SENTISS |