U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210423
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/19/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

ACETAZOLAMIDE

CAPSULE, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 207659 ACCORD HLTHCARE
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210423 ALEMBIC PHARMS LTD
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205301 CADILA
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 040904 HERITAGE PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 207401 MICRO LABS LTD INDIA
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204691 NOSTRUM LABS INC
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203434 NOVAST LABS
Back to Top