Details for New Drug Application (NDA): 215620
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NDA 215620 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 215620
| Tradename: | ACETYLCYSTEINE |
| Applicant: | Indoco |
| Ingredient: | acetylcysteine |
| Patents: | 0 |
Pharmacology for NDA: 215620
| Mechanism of Action | Reduction Activity |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for 215620
Suppliers and Packaging for NDA: 215620
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 215620 | ANDA | Indoco Remedies Limited | 14445-412 | 14445-412-04 | 4 VIAL in 1 CARTON (14445-412-04) / 30 mL in 1 VIAL (14445-412-30) |
| ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 215620 | ANDA | Almaject, Inc. | 72611-860 | 72611-860-04 | 4 VIAL, SINGLE-DOSE in 1 CARTON (72611-860-04) / 30 mL in 1 VIAL, SINGLE-DOSE (72611-860-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 6GM/30ML (200MG/ML) | ||||
| Approval Date: | Feb 23, 2022 | TE: | AP | RLD: | No | ||||
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