APPLICATION
ANDA088366
TYPE
ANDA
ORIGINAL APPROVAL
1984-06-13
LATEST ACTION
2001-02-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMMONIUM CHLORIDE IN PLASTIC CONTAINERPrescription
AMMONIUM CHLORIDE 5MEQ/ML · INJECTABLE · INJECTION
Approval history
2001-02-15Manufacturing (CMC) · Supplement 15AP
1999-10-20Manufacturing (CMC) · Supplement 13AP
1999-10-20Labeling · Supplement 14AP
1999-02-01Manufacturing (CMC) · Supplement 12AP
1996-10-22Manufacturing (CMC) · Supplement 8AP
1996-10-03Manufacturing (CMC) · Supplement 9AP
1996-08-01Manufacturing (CMC) · Supplement 11AP
1993-12-22Manufacturing (CMC) · Supplement 6AP
1987-05-04Manufacturing (CMC) · Supplement 5AP
1987-05-04Manufacturing (CMC) · Supplement 4AP
1986-09-03Manufacturing (CMC) · Supplement 3AP
1986-09-03Manufacturing (CMC) · Supplement 2AP
1984-06-13OriginalAP
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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