Details for New Drug Application (NDA): 217182
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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 217182
Tradename: | ACETYLCYSTEINE |
Applicant: | Steriscience Speclts |
Ingredient: | acetylcysteine |
Patents: | 0 |
Pharmacology for NDA: 217182
Mechanism of Action | Reduction Activity |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 217182
Suppliers and Packaging for NDA: 217182
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 217182 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-111 | 70594-111-02 | 4 VIAL in 1 CARTON (70594-111-02) / 30 mL in 1 VIAL (70594-111-01) |
ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 217182 | ANDA | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-001 | 83270-001-04 | 4 VIAL, SINGLE-DOSE in 1 CARTON (83270-001-04) / 30 mL in 1 VIAL, SINGLE-DOSE (83270-001-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 6GM/30ML (200MG/ML) | ||||
Approval Date: | Apr 19, 2023 | TE: | AP | RLD: | No |
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