Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077314
Company: DR REDDYS LABS LTD

Products on ANDA 077314

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 077314

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2005	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 077314

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