Details for New Drug Application (NDA): 013601
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NDA 013601 describes MUCOMYST, which is a drug marketed by Apothecon and Mead Johnson and is included in two NDAs. Additional details are available on the MUCOMYST profile page.
The generic ingredient in MUCOMYST is acetylcysteine; isoproterenol hydrochloride. There are three drug master file entries for this compound. Additional details are available on the acetylcysteine; isoproterenol hydrochloride profile page.
The generic ingredient in MUCOMYST is acetylcysteine; isoproterenol hydrochloride. There are three drug master file entries for this compound. Additional details are available on the acetylcysteine; isoproterenol hydrochloride profile page.
Summary for 013601
| Tradename: | MUCOMYST |
| Applicant: | Apothecon |
| Ingredient: | acetylcysteine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 013601
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION, ORAL | Strength | 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION, ORAL | Strength | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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