Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073509
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
09/30/1992 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
10/25/2002 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/22/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/07/2000 SUPPL-6 Labeling

Label is not available on this site.

01/07/2000 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/03/1996 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/22/1996 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/09/1995 SUPPL-1 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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