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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073510
Company: HOSPIRA

Products on ANDA 073510

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073510

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
02/10/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 073510

MORPHINE SULFATE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DURAMORPH PF	MORPHINE SULFATE	1MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018565	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	073510	HOSPIRA

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