Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 060101
Company: KING PHARMS LLC

Products on ANDA 060101

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENICILLIN G PROCAINE	PENICILLIN G PROCAINE	600,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	Yes
PENICILLIN G PROCAINE	PENICILLIN G PROCAINE	300,000 UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060101

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/1948	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/24/2019	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
07/02/2018	SUPPL-38	Labeling-Container/Carton Labels		Label is not available on this site.
12/16/2015	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
07/02/2018	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
12/16/2015	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
07/02/2018	SUPPL-31	Labeling		Label is not available on this site.
04/23/2004	SUPPL-20	Labeling		Label is not available on this site.
04/12/2001	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
04/20/1998	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/02/1993	SUPPL-16	Labeling		Label is not available on this site.
07/30/1993	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/31/1989	SUPPL-14	Labeling		Label is not available on this site.
06/28/1995	SUPPL-13	Labeling		Label is not available on this site.
01/14/1991	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.