Details for New Drug Application (NDA): 091684
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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 091684
Tradename: | ACETYLCYSTEINE |
Applicant: | Sagent Pharms Inc |
Ingredient: | acetylcysteine |
Patents: | 0 |
Pharmacology for NDA: 091684
Mechanism of Action | Reduction Activity |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 091684
Suppliers and Packaging for NDA: 091684
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 091684 | ANDA | Sagent Pharmaceuticals | 25021-812 | 25021-812-66 | 4 VIAL in 1 CARTON (25021-812-66) / 30 mL in 1 VIAL |
ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 091684 | ANDA | Sagent Pharmaceuticals | 25021-812 | 25021-812-30 | 4 VIAL in 1 CARTON (25021-812-30) / 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: | Oct 31, 2017 | TE: | AP | RLD: | No |
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