Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019976
Company: FRESENIUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHOSLO CALCIUM ACETATE 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/10/1990 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2016 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/02/2004 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19976slr006,21160slr001ltr.pdf
11/04/2002 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19976slr005ltr.pdf
05/07/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/13/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/27/1992 SUPPL-2 Labeling

Label is not available on this site.

02/22/1993 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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