Drugs@FDA: FDA Approved Drug Products

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

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 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 PHARMS

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