Details for New Drug Application (NDA): 209478
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The generic ingredient in CAROSPIR is spironolactone. There are sixteen drug master file entries for this compound. Forty-three 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: | ⤷ Sign Up | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? |
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