Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071849
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/11/1988 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
10/03/1996 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/26/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/04/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/11/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/27/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

MORPHINE SULFATE

INJECTABLE;INJECTION; 0.5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAMORPH PF MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription Yes AP 018565 WEST-WARD PHARMS INT
MORPHINE SULFATE MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription No AP 071849 HOSPIRA
MORPHINE SULFATE MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription No AP 073509 HOSPIRA

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