Details for New Drug Application (NDA): 209478
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NDA 209478 describes CAROSPIR, which is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from three suppliers. There are eight patents 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 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 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: | 8 |
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 AUTHORIZED GENERIC | Padagis US LLC | 0574-1133 | 0574-1133-04 | 118 mL in 1 BOTTLE (0574-1133-04) |
| CAROSPIR | spironolactone | SUSPENSION;ORAL | 209478 | NDA AUTHORIZED GENERIC | Padagis US LLC | 0574-1133 | 0574-1133-10 | 10 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
| Approval Date: | Aug 4, 2017 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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