FDA NDA · NDA019999

MORPHINE SULFATE (AUTOINJECTOR)

Sponsor: MERIDIAN MEDCL TECHN

APPLICATION

NDA019999

TYPE

NDA

ORIGINAL APPROVAL

1990-07-12

LATEST ACTION

2019-10-07

ROUTE

INTRAMUSCULAR

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

MORPHINE SULFATE (AUTOINJECTOR) · ReferenceDiscontinued

MORPHINE SULFATE 10MG/0.7ML (10MG/0.7ML) · SOLUTION · INTRAMUSCULAR

2019-10-07Labeling · Supplement 23 · standard — Label ↗AP

2016-12-16Labeling · Supplement 21 · standard — Label ↗AP

2016-12-16Labeling · Supplement 22 · standard — Label ↗AP

2013-10-09Manufacturing (CMC) · Supplement 20 · standardAP

2013-08-14Manufacturing (CMC) · Supplement 19 · standardAP

2002-05-29Manufacturing (CMC) · Supplement 8 · standardAP

2001-12-18Manufacturing (CMC) · Supplement 7 · standardAP

2000-11-21Manufacturing (CMC) · Supplement 6 · standardAP

1999-12-14Manufacturing (CMC) · Supplement 5 · standardAP

1999-07-13Manufacturing (CMC) · Supplement 4 · standardAP

1998-10-23Manufacturing (CMC) · Supplement 3 · standardAP

1997-10-28Manufacturing (CMC) · Supplement 2 · standardAP

1996-03-27Manufacturing (CMC) · Supplement 1 · standardAP

1990-07-12Type 5 - New Formulation or New Manufacturer · Original · standardAP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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