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Details for New Drug Application (NDA): 203624
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NDA 203624 describes ACETYLCYSTEINE, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms Inc, Zydus Pharms, Alvogen Inc, Hospira, Luitpold, and Roxane, and is included in eighteen NDAs. It is available from nine 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
Summary for 203624
| Tradename: | ACETYLCYSTEINE |
| Applicant: | Mylan Institutional |
| Ingredient: | acetylcysteine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 203624
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 6GM/30ML (200MG/ML) | ||||
| Approval Date: | Jun 19, 2015 | TE: | RLD: | No | |||||
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