Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201695
Company: NOVEL LABS INC

Products on ANDA 201695

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201695

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Therapeutic Equivalents for ANDA 201695

FAMOTIDINE

FOR SUSPENSION;ORAL; 40MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217529	AJANTA PHARMA LTD
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	201995	AKORN
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	216400	ALKEM LABS LTD
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	216427	AMNEALS PHARMS
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217330	ANNORA PHARMA
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217137	CARNEGIE
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217605	CEROVENE INC
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	090440	LUPIN LTD
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217842	MICRO LABS
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	091020	NAVINTA LLC
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	201695	NOVEL LABS INC
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	215043	NOVITIUM PHARMA
FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217655	UPSHER SMITH LABS