Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 063014
Company: WATSON LABS INC

Products on ANDA 063014

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	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063014

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/1988	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063014Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2000	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
02/06/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
01/27/1995	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/11/1994	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/11/1994	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/13/1994	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/02/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/17/1993	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/03/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/23/1991	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/03/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/14/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/07/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.