Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071051
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASTRAMORPH PF 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
10/07/1986 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
10/21/2005 SUPPL-14 Labeling

Label is not available on this site.

09/30/2004 SUPPL-13 Labeling

Label is not available on this site.

10/02/2002 SUPPL-12 Labeling

Label is not available on this site.

12/22/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/25/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/03/1989 SUPPL-7 Labeling

Label is not available on this site.

04/19/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/19/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

ASTRAMORPH PF

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASTRAMORPH PF MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription No AP 071050 FRESENIUS KABI USA
ASTRAMORPH PF MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription No AP 071051 FRESENIUS KABI USA
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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