Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021160
Company: FRESENIUS MEDCL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHOSLO CALCIUM ACETATE 333.5MG CAPSULE;ORAL Discontinued None No No
PHOSLO CALCIUM ACETATE 667MG CAPSULE;ORAL Discontinued None No No
PHOSLO GELCAPS CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription AB Yes 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
04/02/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21160lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21160ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021160_Phoslo.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/22/2016 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
03/24/2016 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
04/12/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
05/27/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
04/29/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
09/12/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
02/21/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
03/29/2011 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021160s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021160s015ltr.pdf
02/02/2004 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19976slr006,21160slr001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/29/2011 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021160s015lbl.pdf
04/02/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21160lbl.pdf

PHOSLO

There are no Therapeutic Equivalents.

PHOSLO GELCAPS

CAPSULE;ORAL; 667MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription No AB 091312 CHARTWELL RX
CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription No AB 202315 HERITAGE PHARMS INC
CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription No AB 077728 HIKMA
CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription No AB 203135 INVAGEN PHARMS
CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription No AB 202127 LUPIN LTD
CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription No AB 203179 NOSTRUM LABS INC
CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription No AB 211038 SUVEN PHARMS
PHOSLO GELCAPS CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription Yes AB 021160 FRESENIUS MEDCL

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