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DIAMOX

NDA

ACETAZOLAMIDE | N012945 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

1 strength0 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 Chain6 active DMFs3 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

ZAKLADY FARMACEUTYCZNE POLPHARMA SAACETAZOLAMIDE

DMF 103831993

IDT AUSTRALIA LTDACETAZOLAMIDE USP

DMF 129971998

NAKODA CHEMICALS LTDACETAZOLAMIDE

DMF 197632006

EMCURE PHARMACEUTICALS LTDACETAZOLAMIDE USP

DMF 202992007

CTX LIFE SCIENCES PVT LTDACETAZOLAMIDE USP

DMF 230142009

GLAND PHARMA LTDACETAZOLAMIDE

DMF 376162022

KV PHARMACEUTICAL COInactiveACETAZOLAMIDE 500MG SRC

DMF 25611975

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveACETAZOLAMIDE

DMF 28331977

CAMBREX PROFARMACO MILANO SRLInactiveACETAZOLAMIDE

DMF 46471982

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.