U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213342
Company: ACCORD HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription AB No No
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 100MG TABLET;ORAL Prescription AB No No
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 300MG TABLET;ORAL Prescription AB No No
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 400MG TABLET;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/07/2020 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2023 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

HYDROXYCHLOROQUINE SULFATE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 213342 ACCORD HLTHCARE
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 201691 ALKALOIDA ZRT
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 210577 AMNEAL PHARMS CO
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 210441 APPCO
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040274 AUROBINDO PHARMA USA
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 210543 CHARTWELL RX
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040150 CREEKWOOD PHARMS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040766 IPCA LABS LTD
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 210959 LAURUS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040104 SANDOZ
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 212902 SENORES PHARMS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040081 TEVA PHARMS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040657 ZYDUS PHARMS USA INC
PLAQUENIL HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription Yes AB 009768 ADVANZ PHARMA

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 100MG TABLET;ORAL Prescription No AB 213342 ACCORD HLTHCARE
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 100MG TABLET;ORAL Prescription No AB 210441 APPCO

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 300MG TABLET;ORAL Prescription No AB 213342 ACCORD HLTHCARE
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 300MG TABLET;ORAL Prescription No AB 210441 APPCO

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 400MG TABLET;ORAL Prescription No AB 213342 ACCORD HLTHCARE
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 400MG TABLET;ORAL Prescription No AB 210441 APPCO
Back to Top