APPLICATION
ANDA085863
TYPE
ANDA
ORIGINAL APPROVAL
1979-03-16
LATEST ACTION
2000-10-23
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
THEOPHYLLINE · ReferenceDiscontinued
THEOPHYLLINE 80MG/15ML · ELIXIR · ORAL
Approval history
2000-10-23Manufacturing (CMC) · Supplement 61AP
1997-03-06Labeling · Supplement 59AP
1997-01-14Manufacturing (CMC) · Supplement 58AP
1996-04-04Labeling · Supplement 57AP
1992-07-07Labeling · Supplement 56AP
1991-04-23Manufacturing (CMC) · Supplement 55AP
1991-03-11Manufacturing (CMC) · Supplement 53AP
1990-09-28Manufacturing (CMC) · Supplement 54AP
1990-03-28Labeling · Supplement 52AP
1989-10-04Labeling · Supplement 51AP
1989-02-08Manufacturing (CMC) · Supplement 48AP
1989-02-08Manufacturing (CMC) · Supplement 49AP
1988-12-15Manufacturing (CMC) · Supplement 46AP
1988-12-15Manufacturing (CMC) · Supplement 47AP
1988-12-15Labeling · Supplement 45AP
1987-03-17Manufacturing (CMC) · Supplement 44AP
1983-02-18Manufacturing (CMC) · Supplement 42AP
1979-03-16OriginalAP
1970-11-21Manufacturing (CMC) · Supplement 1AP
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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