Details for New Drug Application (NDA): 208112
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NDA 208112 describes METHYLNALTREXONE BROMIDE, which is a drug marketed by Actavis Llc and is included in one NDA. Additional details are available on the METHYLNALTREXONE BROMIDE profile page.
The generic ingredient in METHYLNALTREXONE BROMIDE is methylnaltrexone bromide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methylnaltrexone bromide profile page.
The generic ingredient in METHYLNALTREXONE BROMIDE is methylnaltrexone bromide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methylnaltrexone bromide profile page.
Summary for 208112
| Tradename: | METHYLNALTREXONE BROMIDE |
| Applicant: | Actavis Llc |
| Ingredient: | methylnaltrexone bromide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 8MG/0.4ML (8MG/0.4ML) | ||||
| Approval Date: | Aug 26, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 12MG/0.6ML (12MG/0.6ML) | ||||
| Approval Date: | Aug 26, 2024 | TE: | AP | RLD: | No | ||||
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