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Details for New Drug Application (NDA): 087846

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NDA 087846 describes TOFRANIL, which is a drug marketed by Novartis and Mallinckrodt Inc and is included in five NDAs. It is available from two suppliers. 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. Four suppliers are listed for this compound. Additional details are available on the imipramine pamoate profile page.

Summary for NDA: 087846

Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 087846

Suppliers and Packaging for NDA: 087846

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
imipramine hydrochloride
TABLET;ORAL 087846 ANDA Mallinckrodt, Inc. 0406-9922 0406-9922-01 100 TABLET, SUGAR COATED in 1 BOTTLE (0406-9922-01)
imipramine hydrochloride
TABLET;ORAL 087846 ANDA Mallinckrodt, Inc. 0406-9922 0406-9922-03 30 TABLET, SUGAR COATED in 1 BOTTLE (0406-9922-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 22, 1984TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.