Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078916
Company: ALEMBIC PHARMS LTD

Products on ANDA 078916

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	AB	No	No
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078916

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2009	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/11/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/22/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
07/15/2010	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078916

FAMOTIDINE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	078916	ALEMBIC PHARMS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	215630	ALKEM LABS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	217375	ALKEM LABS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	215767	ANNORA PHARMA
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075611	APOTEX
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	215689	ASCENT PHARMS INC
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	206530	AUROBINDO PHARMA LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075805	CARLSBAD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075786	CHARTWELL RX
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	217669	CONTRACT PHARMACAL
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075718	DR REDDYS LABS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	218181	GRAVITI PHARMS
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075511	IVAX SUB TEVA PHARMS
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075302	MANKIND PHARMA
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	216441	ZYDUS PHARMS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	078916	ALEMBIC PHARMS LTD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	215630	ALKEM LABS LTD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	217375	ALKEM LABS LTD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	215767	ANNORA PHARMA
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075611	APOTEX
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	215689	ASCENT PHARMS INC
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	206530	AUROBINDO PHARMA LTD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075805	CARLSBAD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075786	CHARTWELL RX
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	217669	CONTRACT PHARMACAL
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075718	DR REDDYS LABS LTD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	218181	GRAVITI PHARMS
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075511	IVAX SUB TEVA PHARMS
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075302	MANKIND PHARMA
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	216441	ZYDUS PHARMS