Application 209478
- Type
- NDA
- Sponsor
- CMP DEV LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CAROSPIR | SPIRONOLACTONE | SUSPENSION;ORAL | 25MG/5ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17856-0120 | CaroSpir | CaroSpir | ATLANTIC BIOLOGICALS CORP. | NDA | Current |
| 17856-0120 | CaroSpir | CaroSpir | ATLANTIC BIOLOGICALS CORP. | NDA | Current |
| 17856-0120 | CaroSpir | CaroSpir | ATLANTIC BIOLOGICALS CORP. | NDA | Current |
| 46287-020 | CaroSpir | CaroSpir | CMP Pharma, Inc. | NDA | Current |
| 46287-020 | CaroSpir | CaroSpir | CMP Pharma, Inc. | NDA | Current |
| 46287-020 | CaroSpir | CaroSpir | CMP Pharma, Inc. | NDA | Current |
| 46287-020 | CaroSpir | CaroSpir | CMP Pharma, Inc. | NDA | Current |