Details for New Drug Application (NDA): 072323
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The generic ingredient in ACETYLCYSTEINE is acetylcysteine. There are three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
Summary for 072323
Tradename: | ACETYLCYSTEINE |
Applicant: | Roxane |
Ingredient: | acetylcysteine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 072323
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION, ORAL | Strength | 10% | ||||
Approval Date: | Apr 30, 1992 | TE: | RLD: | No |
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