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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076178
Company: EPIC PHARMA LLC

Products on ANDA 076178

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIZATIDINE	NIZATIDINE	150MG	CAPSULE;ORAL	Prescription	AB	No	No
NIZATIDINE	NIZATIDINE	300MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076178

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/05/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76178f.ta.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2013	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/31/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076178

NIZATIDINE

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIZATIDINE	NIZATIDINE	150MG	CAPSULE;ORAL	Prescription	No	AB	077314	DR REDDYS LABS LTD
NIZATIDINE	NIZATIDINE	150MG	CAPSULE;ORAL	Prescription	No	AB	076178	EPIC PHARMA LLC
NIZATIDINE	NIZATIDINE	150MG	CAPSULE;ORAL	Prescription	No	AB	090618	GLENMARK PHARMS INC
NIZATIDINE	NIZATIDINE	150MG	CAPSULE;ORAL	Prescription	No	AB	075616	WATSON LABS

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIZATIDINE	NIZATIDINE	300MG	CAPSULE;ORAL	Prescription	No	AB	077314	DR REDDYS LABS LTD
NIZATIDINE	NIZATIDINE	300MG	CAPSULE;ORAL	Prescription	No	AB	076178	EPIC PHARMA LLC
NIZATIDINE	NIZATIDINE	300MG	CAPSULE;ORAL	Prescription	No	AB	090618	GLENMARK PHARMS INC
NIZATIDINE	NIZATIDINE	300MG	CAPSULE;ORAL	Prescription	No	AB	075616	WATSON LABS

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