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ACETAZOLAMIDE

ANDA

ACETAZOLAMIDE | A209734 | STRIDES PHARMA GLOBAL PTE LTD

2 strengths0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Nov 27, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 125MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 20, 2017

No patent or exclusivity listings for this strength.

#002 — 250MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 20, 2017