Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075401
Company: ACTAVIS LABS FL INC

Products on ANDA 075401

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAZTIA XT	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB4	No	No
TAZTIA XT	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB4	No	No
TAZTIA XT	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB4	No	No
TAZTIA XT	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB4	No	No
TAZTIA XT	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB4	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075401

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/2003	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75401TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075401.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2011	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
07/29/2008	SUPPL-11	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075401

TAZTIA XT

CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB4

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	091022	SANDOZ
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	090421	SUN PHARM
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	206641	ZYDUS PHARMS
TAZTIA XT	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	075401	ACTAVIS LABS FL INC
TIAZAC	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB4	020401	BAUSCH

CAPSULE, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB4

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	091022	SANDOZ
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	090421	SUN PHARM
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	206641	ZYDUS PHARMS
TAZTIA XT	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	075401	ACTAVIS LABS FL INC
TIAZAC	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB4	020401	BAUSCH

CAPSULE, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB4

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	091022	SANDOZ
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	090421	SUN PHARM
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	206641	ZYDUS PHARMS
TAZTIA XT	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	075401	ACTAVIS LABS FL INC
TIAZAC	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB4	020401	BAUSCH

CAPSULE, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB4

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	091022	SANDOZ
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	090421	SUN PHARM
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	206641	ZYDUS PHARMS
TAZTIA XT	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	075401	ACTAVIS LABS FL INC
TIAZAC	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB4	020401	BAUSCH

CAPSULE, EXTENDED RELEASE;ORAL; 360MG
TE Code = AB4

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	091022	SANDOZ
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	090421	SUN PHARM
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	206641	ZYDUS PHARMS
TAZTIA XT	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB4	075401	ACTAVIS LABS FL INC
TIAZAC	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB4	020401	BAUSCH