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Details for New Drug Application (NDA): 209478
NDA 209478 describes CAROSPIR, which is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the CAROSPIR profile page.
The generic ingredient in CAROSPIR is spironolactone. There are sixteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the spironolactone profile page.
The generic ingredient in CAROSPIR is spironolactone. There are sixteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the spironolactone profile page.
Summary for 209478
| Tradename: | CAROSPIR |
| Applicant: | Cmp Dev Llc |
| Ingredient: | spironolactone |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209478
| Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for 209478
Suppliers and Packaging for NDA: 209478
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAROSPIR | spironolactone | SUSPENSION;ORAL | 209478 | NDA | ATLANTIC BIOLOGICALS CORP. | 17856-0120 | 17856-0120-1 | 72 CUP in 1 BOX (17856-0120-1) > 2.5 mL in 1 CUP |
| CAROSPIR | spironolactone | SUSPENSION;ORAL | 209478 | NDA | CMP Pharma, Inc. | 46287-020 | 46287-020-01 | 473 mL in 1 BOTTLE (46287-020-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
| Approval Date: | Aug 4, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Sign Up | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | CAROSPIR IS INDICATED FOR TREATMENT OF NYHA CLASS III-IV HEART FAILURE AND REDUCED EJECTION FRACTION TO INCREASE SURVIVAL, MANAGE EDEMA, AND TO REDUCE THE NEED FOR HOSPITALIZATION FOR HEART FAILURE | ||||||||
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