APPLICATION
NDA017106
TYPE
NDA
ORIGINAL APPROVAL
1973-05-15
LATEST ACTION
2020-11-20
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ATROPEN · ReferenceDiscontinued
ATROPINE EQ 0.25MG SULFATE/0.3ML · SOLUTION · INTRAMUSCULAR
ATROPEN · ReferenceDiscontinued
ATROPINE EQ 1MG SULFATE/0.7ML · SOLUTION · INTRAMUSCULAR
ATROPEN · ReferenceDiscontinued
ATROPINE EQ 0.5MG SULFATE/0.7ML · SOLUTION · INTRAMUSCULAR
ATROPEN · ReferenceDiscontinued
ATROPINE EQ 2MG SULFATE/0.7ML · SOLUTION · INTRAMUSCULAR
Approval history
2016-05-27Manufacturing (CMC) · Supplement 49 · priorityAP
2015-08-10Manufacturing (CMC) · Supplement 51 · priorityAP
2013-11-14Manufacturing (CMC) · Supplement 45 · priorityAP
2002-06-28Manufacturing (CMC) · Supplement 27 · priorityAP
2002-03-04Manufacturing (CMC) · Supplement 25 · priorityAP
2002-01-07Manufacturing (CMC) · Supplement 26 · priorityAP
2001-06-08Manufacturing (CMC) · Supplement 24 · priorityAP
2001-02-13Manufacturing (CMC) · Supplement 23 · priorityAP
2001-01-31Manufacturing (CMC) · Supplement 22 · priorityAP
2000-10-19Manufacturing (CMC) · Supplement 21 · priorityAP
2000-08-18Manufacturing (CMC) · Supplement 19 · priorityAP
2000-08-16Manufacturing (CMC) · Supplement 20 · priorityAP
1999-10-28Manufacturing (CMC) · Supplement 18 · priorityAP
1999-04-26Manufacturing (CMC) · Supplement 17 · priorityAP
1999-03-16Manufacturing (CMC) · Supplement 16 · priorityAP
1998-08-25Manufacturing (CMC) · Supplement 15 · priorityAP
1998-04-21Labeling · Supplement 14 · standardAP
1997-03-06Manufacturing (CMC) · Supplement 13 · priorityAP
1996-12-17Manufacturing (CMC) · Supplement 12 · priorityAP
1991-03-05Manufacturing (CMC) · Supplement 11 · priorityAP
1990-08-17Manufacturing (CMC) · Supplement 10 · priorityAP
1989-04-04Manufacturing (CMC) · Supplement 9 · priorityAP
1987-08-19Manufacturing (CMC) · Supplement 8 · priorityAP
1986-10-06Manufacturing (CMC) · Supplement 7 · priorityAP
1985-01-14Manufacturing (CMC) · Supplement 6 · priorityAP
1984-06-06Labeling · Supplement 5AP
1979-12-27Manufacturing (CMC) · Supplement 4 · priorityAP
1979-05-10Manufacturing (CMC) · Supplement 3 · priorityAP
1978-07-27Manufacturing (CMC) · Supplement 1 · priorityAP
1973-05-15Type 5 - New Formulation or New Manufacturer · Original · priorityAP
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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