Details for New Drug Application (NDA): 021539
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The generic ingredient in ACETADOTE is acetylcysteine. There are three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
Summary for 021539
Tradename: | ACETADOTE |
Applicant: | Cumberland Pharms |
Ingredient: | acetylcysteine |
Patents: | 5 |
Pharmacology for NDA: 021539
Mechanism of Action | Reduction Activity |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 021539
Suppliers and Packaging for NDA: 021539
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539 | NDA AUTHORIZED GENERIC | Padagis US LLC | 0574-0805 | 0574-0805-30 | 4 VIAL in 1 CARTON (0574-0805-30) / 30 mL in 1 VIAL |
ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539 | NDA | Cumberland Pharmaceuticals Inc. | 66220-207 | 66220-207-30 | 4 VIAL in 1 CARTON (66220-207-30) / 30 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 6GM/30ML (200MG/ML) | ||||
Approval Date: | Jan 23, 2004 | TE: | AP | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 21, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 24, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 24, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS |
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