Details for New Drug Application (NDA): 050095
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NDA 050095 describes CAPASTAT SULFATE, which is a drug marketed by Epic Pharma Llc and is included in one NDA. Additional details are available on the CAPASTAT SULFATE profile page.
The generic ingredient in CAPASTAT SULFATE is capreomycin sulfate. There are three drug master file entries for this compound. Additional details are available on the capreomycin sulfate profile page.
The generic ingredient in CAPASTAT SULFATE is capreomycin sulfate. There are three drug master file entries for this compound. Additional details are available on the capreomycin sulfate profile page.
Summary for 050095
| Tradename: | CAPASTAT SULFATE |
| Applicant: | Epic Pharma Llc |
| Ingredient: | capreomycin sulfate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050095
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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