Details for New Drug Application (NDA): 017090
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NDA 017090 describes TOFRANIL-PM, which is a drug marketed by Specgx Llc and is included in one NDA. Additional details are available on the TOFRANIL-PM profile page.
The generic ingredient in TOFRANIL-PM is imipramine pamoate. There are thirty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the imipramine pamoate profile page.
The generic ingredient in TOFRANIL-PM is imipramine pamoate. There are thirty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the imipramine pamoate profile page.
Summary for 017090
| Tradename: | TOFRANIL-PM |
| Applicant: | Specgx Llc |
| Ingredient: | imipramine pamoate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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