Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083082
Company: HIKMA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE EQ 150MG BASE TABLET;ORAL Prescription AA No Yes
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE EQ 300MG BASE TABLET;ORAL Prescription AA 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
07/09/1975 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
11/10/2009 SUPPL-50 Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/083082s050lbl.pdf
05/31/2007 SUPPL-49 Labeling

Label is not available on this site.

03/21/2006 SUPPL-48 Labeling

Label is not available on this site.

09/29/2005 SUPPL-47 Labeling

Label is not available on this site.

07/11/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2000 SUPPL-40 Labeling

Label is not available on this site.

11/30/2000 SUPPL-39 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/30/2000 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/24/2000 SUPPL-37 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/24/2000 SUPPL-36 Manufacturing (CMC)-Facility

Label is not available on this site.

05/24/2000 SUPPL-35 Labeling

Label is not available on this site.

09/17/1999 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/17/1999 SUPPL-33 Labeling

Label is not available on this site.

09/17/1999 SUPPL-32 Manufacturing (CMC)-New Strength

Label is not available on this site.

05/24/2000 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/24/2000 SUPPL-30 Labeling

Label is not available on this site.

05/24/2000 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/05/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/05/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/05/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/05/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/05/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/02/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/20/1989 SUPPL-21 Bioequivalence

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/10/2009 SUPPL-50 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/083082s050lbl.pdf

CHLOROQUINE PHOSPHATE

TABLET;ORAL; EQ 150MG BASE
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE EQ 150MG BASE TABLET;ORAL Prescription No AA 083082 HIKMA PHARMS
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE EQ 150MG BASE TABLET;ORAL Prescription No AA 090610 IPCA LABS LTD
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE EQ 150MG BASE TABLET;ORAL Prescription No AA 091621 NATCO PHARMA LTD

TABLET;ORAL; EQ 300MG BASE
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE EQ 300MG BASE TABLET;ORAL Prescription No AA 083082 HIKMA PHARMS
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE EQ 300MG BASE TABLET;ORAL Prescription No AA 090249 IPCA LABS LTD
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE EQ 300MG BASE TABLET;ORAL Prescription No AA 090612 NATCO PHARMA LTD

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