Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040609
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE AND ACETIC ACID | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
02/06/2006 | ORIG-1 | Approval |
Label is not available on this site. |
HYDROCORTISONE AND ACETIC ACID
SOLUTION/DROPS;OTIC; 2%;1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE AND ACETIC ACID | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 040609 | COSETTE |
HYDROCORTISONE AND ACETIC ACID | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | Yes | AT | 088759 | TARO |
VOSOL HC | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | Yes | AT | 012770 | SAPTALIS PHARMS |