Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089069
Company: HOSPIRA

Products on ANDA 089069

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089069

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/1986	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
05/05/1999	SUPPL-16	Labeling		Label is not available on this site.
06/08/1998	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/12/1998	SUPPL-13	Labeling		Label is not available on this site.
06/08/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/05/1998	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/21/1998	SUPPL-10	Labeling		Label is not available on this site.
08/24/1994	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/21/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/22/1991	SUPPL-6	Labeling		Label is not available on this site.
08/13/1991	SUPPL-5	Labeling		Label is not available on this site.
01/28/1991	SUPPL-4	Labeling		Label is not available on this site.
08/12/1988	SUPPL-3	Labeling		Label is not available on this site.
11/23/1988	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 089069

PROCAINAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	218135	GLAND PHARMA LTD
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	089069	HOSPIRA
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	088636	INTL MEDICATION
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206332	NEXUS