Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064210
Company: XGEN PHARMS

Products on ANDA 064210

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STREPTOMYCIN SULFATE	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064210

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64210ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/10/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/30/2012	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064210s009lbl.pdf
07/23/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
07/23/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/11/2000	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 064210

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2012	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064210s009lbl.pdf