Details for New Drug Application (NDA): 219194
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NDA 219194 describes ACETYLCYSTEINE, which is a drug marketed by Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Indoco, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Steriscience Speclts, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane, and is included in twenty-four NDAs. It is available from fourteen suppliers. Additional details are available on the ACETYLCYSTEINE profile page.
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.
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 219194
| Tradename: | ACETYLCYSTEINE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | acetylcysteine |
| Patents: | 0 |
Pharmacology for NDA: 219194
| Mechanism of Action | Reduction Activity |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 219194
Suppliers and Packaging for NDA: 219194
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 219194 | ANDA | Somerset Therapeutics, LLC | 70069-018 | 70069-018-25 | 25 VIAL in 1 CARTON (70069-018-25) / 4 mL in 1 VIAL (70069-018-01) |
| ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 219194 | ANDA | Somerset Therapeutics, LLC | 70069-019 | 70069-019-25 | 25 VIAL in 1 CARTON (70069-019-25) / 4 mL in 1 VIAL (70069-019-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION, ORAL | Strength | 10% | ||||
| Approval Date: | Feb 12, 2025 | TE: | AN | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION, ORAL | Strength | 20% | ||||
| Approval Date: | Feb 12, 2025 | TE: | AN | RLD: | No | ||||
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