Details for New Drug Application (NDA): 200644
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NDA 200644 describes ACETYLCYSTEINE, which is a drug marketed by Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Steriscience, 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 200644
| Tradename: | ACETYLCYSTEINE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | acetylcysteine |
| Patents: | 0 |
Pharmacology for NDA: 200644
| Mechanism of Action | Reduction Activity |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 200644
Suppliers and Packaging for NDA: 200644
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 200644 | ANDA | Fresenius Kabi USA, LLC | 63323-963 | 63323-963-44 | 4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-44) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-963-41) |
| ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 200644 | ANDA | Fresenius Kabi USA, LLC | 63323-963 | 63323-963-30 | 4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-30) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-963-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 6GM/30ML (200MG/ML) | ||||
| Approval Date: | Nov 7, 2012 | TE: | AP | RLD: | No | ||||
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