Details for New Drug Application (NDA): 019815
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NDA 019815 describes PROAMATINE, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. Additional details are available on the PROAMATINE profile page.
The generic ingredient in PROAMATINE is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.
The generic ingredient in PROAMATINE is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.
Summary for 019815
| Tradename: | PROAMATINE |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | midodrine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019815
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 6, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 6, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 20, 2002 | TE: | RLD: | Yes | |||||
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