Drugs@FDA: FDA Approved Drug Products

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

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