Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065068
Company: SANDOZ

Products on ANDA 065068

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENICILLIN G SODIUM	PENICILLIN G SODIUM	5,000,000 UNITS/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065068

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65068Ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2020	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
08/18/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/11/2012	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065068s013lbl.pdf
09/30/2004	SUPPL-7	Labeling		Label is not available on this site.
09/20/2002	SUPPL-4	Labeling		Label is not available on this site.
12/06/2001	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for ANDA 065068

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2012	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065068s013lbl.pdf