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TRIMIPRAMINE MALEATE

ANDA

TRIMIPRAMINE MALEATE | A077361 | ELITE LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain1 active DMF4 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

LUNDBECK PHARMACEUTICALS ITALY SPATRIMIPRAMINE MALEATE

DMF 59001985

RHONE POULENC INCInactiveTRIMIPRAMINE MALEATE

DMF 40781981

PCASInactiveTRIMIPRAMINE MALEATE

DMF 65231986

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveTRIMIPRAMINE MALEATE

DMF 176652004

SANOFI CHIMIEInactiveTRIMIPRAMINE MALEATE

DMF 251062011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 7, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 25MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 2, 2006

No patent or exclusivity listings for this strength.

#002 — EQ 50MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 2, 2006

#003 — EQ 100MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 2, 2006