Details for New Drug Application (NDA): 021539
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NDA 021539 describes ACETADOTE, which is a drug marketed by Cumberland Pharms and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ACETADOTE profile page.
The generic ingredient in ACETADOTE is acetylcysteine. There are three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
The generic ingredient in ACETADOTE is acetylcysteine. There are three drug master file entries for this compound. Seventeen 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: | ⤷ Subscribe | Patent Expiration: | May 21, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Aug 24, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS | ||||||||
| Patent: | ⤷ Subscribe | 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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