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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202127
Company: LUPIN LTD
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
07/09/2015 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202127Orig1s000ltr.pdf

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 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 217205 SQUARE PHARMS
CALCIUM ACETATE CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription No AB 211038 SUVEN PHARMS
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