Details for New Drug Application (NDA): 011836
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NDA 011836 describes PRESAMINE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the PRESAMINE profile page.
The generic ingredient in PRESAMINE is imipramine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
The generic ingredient in PRESAMINE is imipramine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
Summary for 011836
| Tradename: | PRESAMINE |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | imipramine hydrochloride |
| Patents: | 0 |
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 006
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 007
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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