Details for New Drug Application (NDA): 204797
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The generic ingredient in ACETYLCYSTEINE 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 204797
Tradename: | ACETYLCYSTEINE |
Applicant: | Exela Pharma |
Ingredient: | acetylcysteine |
Patents: | 0 |
Pharmacology for NDA: 204797
Mechanism of Action | Reduction Activity |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 204797
Suppliers and Packaging for NDA: 204797
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 204797 | ANDA | Exela Pharma Sciences, LLC | 51754-0104 | 51754-0104-7 | 4 VIAL in 1 CARTON (51754-0104-7) / 30 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 6GM/30ML (200MG/ML) | ||||
Approval Date: | Apr 15, 2021 | TE: | RLD: | No |
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