Details for New Drug Application (NDA): 214177
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NDA 214177 describes ACETYLCYSTEINE, which is a drug marketed by Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Onesource Specialty, Regcon Holdings, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Zydus Pharms, Alvogen, Am Regent, Conba Usa, Hospira, and Roxane, and is included in twenty-five NDAs. It is available from twelve 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
Summary for 214177
| Tradename: | ACETYLCYSTEINE |
| Applicant: | Conba Usa |
| Ingredient: | acetylcysteine |
| Patents: | 0 |
Pharmacology for NDA: 214177
| Mechanism of Action | Reduction Activity |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 214177
Suppliers and Packaging for NDA: 214177
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 214177 | ANDA | Cameron Pharmaceuticals | 42494-435 | 42494-435-25 | 25 VIAL in 1 CARTON (42494-435-25) / 4 mL in 1 VIAL |
| ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 214177 | ANDA | Cameron Pharmaceuticals | 42494-436 | 42494-436-25 | 25 VIAL in 1 CARTON (42494-436-25) / 4 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION, ORAL | Strength | 10% | ||||
| Approval Date: | Mar 14, 2025 | TE: | AN | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION, ORAL | Strength | 20% | ||||
| Approval Date: | Mar 14, 2025 | TE: | AN | RLD: | No | ||||
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