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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216521
Company: SCIEGEN PHARMS INC

Products on ANDA 216521

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	AB	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	AB	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	TABLET;ORAL	Prescription	AB	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216521

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216521

DILTIAZEM HYDROCHLORIDE

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDIZEM	DILTIAZEM HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	Yes	AB	018602	BAUSCH
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	216521	SCIEGEN PHARMS INC
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	074185	TEVA

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDIZEM	DILTIAZEM HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	Yes	AB	018602	BAUSCH
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	216521	SCIEGEN PHARMS INC
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	074185	TEVA

TABLET;ORAL; 90MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDIZEM	DILTIAZEM HYDROCHLORIDE	90MG	TABLET;ORAL	Prescription	Yes	AB	018602	BAUSCH
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	TABLET;ORAL	Prescription	No	AB	216521	SCIEGEN PHARMS INC
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	TABLET;ORAL	Prescription	No	AB	074185	TEVA

TABLET;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDIZEM	DILTIAZEM HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	Yes	AB	018602	BAUSCH
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	216521	SCIEGEN PHARMS INC
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	074185	TEVA

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