Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202127
Company: LUPIN LTD

Products on ANDA 202127

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202127

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

Therapeutic Equivalents for ANDA 202127

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