Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080416
Company: HOSPIRA

Products on ANDA 080416

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROCAINE HYDROCHLORIDE	PROCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Discontinued	None	No	No
PROCAINE HYDROCHLORIDE	PROCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080416

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/1972	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
05/15/2000	SUPPL-34	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/02/2000	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
07/20/1998	SUPPL-32	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
07/20/1998	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
10/21/1997	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
10/03/1996	SUPPL-29	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/22/1996	SUPPL-28	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/20/1994	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
08/03/1989	SUPPL-25	Labeling		Label is not available on this site.
04/21/1988	SUPPL-24	Labeling		Label is not available on this site.
05/06/1987	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
09/14/1982	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.