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TEMARIL

NDA

TRIMEPRAZINE TARTRATE | N011316 | ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF3 inactive

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

PCASTRIMEPRAZINE TARTRATE

DMF 158172002

LONZA RIVERSIDEInactiveTRIMEPRAZINE TARTRATE

DMF 26681976

PCASInactiveTRIMEPRAZINE TARTRATE USP

DMF 56031984

RHONE-POULENC SANTE INCInactiveTRIMEPRAZINE TARTRATE

DMF 59471985

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

Products (3)

Sort:

#001 — EQ 2.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — EQ 2.5MG BASE/5ML

0 patents0 exclusivities▾

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — EQ 5MG BASE

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982