Details for New Drug Application (NDA): 050495
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NDA 050495 describes AMIKIN, which is a drug marketed by Apothecon and is included in four NDAs. Additional details are available on the AMIKIN profile page.
The generic ingredient in AMIKIN is amikacin sulfate. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
The generic ingredient in AMIKIN is amikacin sulfate. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
Summary for 050495
| Tradename: | AMIKIN |
| Applicant: | Apothecon |
| Ingredient: | amikacin sulfate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050495
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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