Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215572
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SPIRONOLACTONE | SPIRONOLACTONE | 25MG/5ML | SUSPENSION;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
09/05/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215572Orig1s000ltr.pdf |
SPIRONOLACTONE
SUSPENSION;ORAL; 25MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CAROSPIR | SPIRONOLACTONE | 25MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 209478 | CMP DEV LLC |
SPIRONOLACTONE | SPIRONOLACTONE | 25MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 215572 | AMNEAL |