Details for New Drug Application (NDA): 072489
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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 072489
Tradename: | ACETYLCYSTEINE |
Applicant: | Am Regent |
Ingredient: | acetylcysteine |
Patents: | 0 |
Pharmacology for NDA: 072489
Mechanism of Action | Reduction Activity |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 072489
Suppliers and Packaging for NDA: 072489
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 072489 | ANDA | American Regent, Inc. | 0517-7504 | 0517-7504-25 | 25 VIAL, GLASS in 1 TRAY (0517-7504-25) / 4 mL in 1 VIAL, GLASS |
ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 072489 | ANDA | American Regent, Inc. | 0517-7510 | 0517-7510-03 | 3 VIAL, GLASS in 1 BOX (0517-7510-03) / 10 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION, ORAL | Strength | 10% | ||||
Approval Date: | Jul 28, 1995 | TE: | AN | RLD: | No |
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