Details for New Drug Application (NDA): 083827
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NDA 083827 describes PRAMINE, which is a drug marketed by Alra and is included in one NDA. Additional details are available on the PRAMINE profile page.
The generic ingredient in PRAMINE is imipramine hydrochloride. There are thirty-four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
The generic ingredient in PRAMINE is imipramine hydrochloride. There are thirty-four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
Summary for 083827
| Tradename: | PRAMINE |
| Applicant: | Alra |
| Ingredient: | imipramine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| 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 002
| 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 003
| 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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