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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075486
Company: HIKMA

Products on ANDA 075486

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FAMOTIDINE PRESERVATIVE FREE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075486

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/2001	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75486ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75486TA.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
05/20/2008	SUPPL-7	Labeling		Label is not available on this site.
11/08/2002	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Therapeutic Equivalents for ANDA 075486

FAMOTIDINE PRESERVATIVE FREE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FAMOTIDINE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075709	FRESENIUS KABI USA
FAMOTIDINE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075488	HIKMA
FAMOTIDINE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078641	MYLAN LABS LTD
FAMOTIDINE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075651	SAGENT
FAMOTIDINE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075684	SAGENT
FAMOTIDINE PRESERVATIVE FREE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075813	FRESENIUS KABI USA
FAMOTIDINE PRESERVATIVE FREE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075486	HIKMA
FAMOTIDINE PRESERVATIVE FREE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078642	MYLAN LABS LTD
FAMOTIDINE PRESERVATIVE FREE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075622	SAGENT
FAMOTIDINE PRESERVATIVE FREE	FAMOTIDINE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075825	SAGENT

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