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Details for New Drug Application (NDA): 087846
The generic ingredient in TOFRANIL 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 087846
Tradename: | TOFRANIL |
Applicant: | Specgx Llc |
Ingredient: | imipramine hydrochloride |
Patents: | 0 |
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 | 0406-9920-01 | 100 TABLET, SUGAR COATED in 1 BOTTLE (0406-9920-01) |
IMIPRAMINE HYDROCHLORIDE | imipramine hydrochloride | TABLET;ORAL | 087846 | ANDA | SpecGx LLC | 0406-9920 | 0406-9920-03 | 30 TABLET, SUGAR COATED in 1 BOTTLE (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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