Details for New Drug Application (NDA): 203853
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NDA 203853 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-three 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 203853
| Tradename: | ACETYLCYSTEINE |
| Applicant: | Alvogen |
| Ingredient: | acetylcysteine |
| Patents: | 0 |
Pharmacology for NDA: 203853
| Mechanism of Action | Reduction Activity |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 203853
Suppliers and Packaging for NDA: 203853
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 203853 | ANDA | Fresenius Kabi USA, LLC | 63323-690 | 63323-690-30 | 3 VIAL in 1 CARTON (63323-690-30) / 30 mL in 1 VIAL (63323-690-22) |
| ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 203853 | ANDA | Fresenius Kabi USA, LLC | 63323-690 | 63323-690-44 | 3 VIAL in 1 CARTON (63323-690-44) / 30 mL in 1 VIAL (63323-690-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION, ORAL | Strength | 20% | ||||
| Approval Date: | Jun 21, 2012 | TE: | AN | RLD: | No | ||||
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