Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075773
Company: FRESENIUS KABI USA

• Other Important Information from FDA

Products on ANDA 075773

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	30MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075773

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2002	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75773.TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075773.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.