Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040104
Company: SANDOZ
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/30/1995 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/28/2007 SUPPL-15 Labeling

Label is not available on this site.

04/19/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/2000 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/20/1999 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/25/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/05/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/15/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/15/1996 SUPPL-1 Manufacturing (CMC)

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 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 040760 HIKMA 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 040274 MYLAN
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040104 SANDOZ
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040081 TEVA PHARMS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 210441 TWI PHARMS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040133 WATSON LABS
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 CONCORDIA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English