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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211038
Company: SUVEN PHARMS

Products on ANDA 211038

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 211038

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2020	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/17/2020	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 211038

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
PHOSLO GELCAPS	CALCIUM ACETATE	667MG	CAPSULE;ORAL	Prescription	Yes	AB	021160	FRESENIUS MEDCL

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