Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075813
Company: FRESENIUS KABI USA
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 No
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)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75813TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/05/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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 075651 ATHENEX INC
FAMOTIDINE FAMOTIDINE 10MG/ML INJECTABLE;INJECTION Prescription No AP 075684 ATHENEX INC
FAMOTIDINE FAMOTIDINE 10MG/ML INJECTABLE;INJECTION Prescription No AP 075709 FRESENIUS KABI USA
FAMOTIDINE FAMOTIDINE 10MG/ML INJECTABLE;INJECTION Prescription No AP 078641 MYLAN LABS LTD
FAMOTIDINE FAMOTIDINE 10MG/ML INJECTABLE;INJECTION Prescription No AP 075488 WEST-WARD PHARMS INT
FAMOTIDINE PRESERVATIVE FREE FAMOTIDINE 10MG/ML INJECTABLE;INJECTION Prescription No AP 075622 ATHENEX INC
FAMOTIDINE PRESERVATIVE FREE FAMOTIDINE 10MG/ML INJECTABLE;INJECTION Prescription No AP 075825 ATHENEX INC
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 078642 MYLAN LABS LTD
FAMOTIDINE PRESERVATIVE FREE FAMOTIDINE 10MG/ML INJECTABLE;INJECTION Prescription No AP 075486 WEST-WARD PHARMS INT

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