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TOLAZAMIDE

NDA

TOLAZAMIDE | N018894 | COSETTE PHARMACEUTICALS 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 Chain0 active DMFs6 inactive

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

ZENITH LABORATORIES INCInactiveTOLAZAMIDE POWDER

DMF 14271969

DIPHARMA FRANCIS SRLInactiveTOLAZAMIDE

DMF 47061982

COSMA SPAInactiveTOLAZAMIDE

DMF 47351982

LAPORTE ORGANICS FRANCIS SPAInactiveTOLAZAMIDE USP

DMF 55731984

HOECHST CELANESE CORPInactiveTOLAZAMIDE USP

DMF 58191985

DINAMITE DIPHARMA SPAInactiveTOLAZAMIDE

DMF 63941982

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

Products (3)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 2, 1984

No patent or exclusivity listings for this strength.

#002 — 250MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 2, 1984

#003 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 2, 1984