Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077728
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE;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
02/26/2008 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077728s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077728s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

CALCIUM ACETATE

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 201658 AMNEAL PHARMS
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 203135 INVAGEN PHARMS
CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription No AB 203298 LOTUS PHARM CO LTD
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 077728 WEST-WARD PHARMS INT
PHOSLO GELCAPS CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription Yes AB 021160 FRESENIUS MEDCL

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