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Details for New Drug Application (NDA): 087846
NDA 087846 describes TOFRANIL, which is a drug marketed by Novartis and Specgx Llc and is included in three NDAs. It is available from one supplier. Additional details are available on the TOFRANIL profile page.
The generic ingredient in TOFRANIL is imipramine pamoate. There are thirty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the imipramine pamoate profile page.
The generic ingredient in TOFRANIL is imipramine pamoate. There are thirty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the imipramine pamoate profile page.
Summary for 087846
| Tradename: | TOFRANIL |
| Applicant: | Specgx Llc |
| Ingredient: | imipramine hydrochloride |
| Patents: | 0 |
| Therapeutic Class: | Antidepressants |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 087846
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | imipramine hydrochloride | TABLET;ORAL | 087846 | ANDA | SpecGx LLC | 0406-9920 | N | 0406-9920-01 |
| IMIPRAMINE HYDROCHLORIDE | imipramine hydrochloride | TABLET;ORAL | 087846 | ANDA | SpecGx LLC | 0406-9920 | N | 0406-9920-03 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | May 22, 1984 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 22, 1984 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | May 22, 1984 | TE: | AB | RLD: | No | ||||
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