APPLICATION
ANDA087400
TYPE
ANDA
ORIGINAL APPROVAL
1983-01-11
LATEST ACTION
2023-08-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
THEOPHYLLINEPrescription
THEOPHYLLINE 100MG · TABLET, EXTENDED RELEASE · ORAL
THEOPHYLLINEPrescription
THEOPHYLLINE 200MG · TABLET, EXTENDED RELEASE · ORAL
THEOPHYLLINEPrescription
THEOPHYLLINE 300MG · TABLET, EXTENDED RELEASE · ORAL
THEOPHYLLINEPrescription
THEOPHYLLINE 450MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-08-09Manufacturing (CMC) · Supplement 35AP
1998-01-28Manufacturing (CMC) · Supplement 29AP
1997-07-07Manufacturing (CMC) · Supplement 27AP
1997-07-07Manufacturing (CMC) · Supplement 26AP
1997-02-07Labeling · Supplement 28AP
1996-10-17Labeling · Supplement 25AP
1996-01-23Labeling · Supplement 24AP
1993-02-22Manufacturing (CMC) · Supplement 23AP
1992-02-27Labeling · Supplement 22AP
1991-09-03Bioequivalence · Supplement 21AP
1990-04-02Labeling · Supplement 19AP
1990-04-02Labeling · Supplement 36AP
1989-10-06Labeling · Supplement 18AP
1989-05-15Bioequivalence · Supplement 20AP
1989-03-24Labeling · Supplement 17AP
1988-06-20Manufacturing (CMC) · Supplement 16AP
1987-05-11Manufacturing (CMC) · Supplement 8AP
1985-12-20Manufacturing (CMC) · Supplement 6AP
1985-12-20Manufacturing (CMC) · Supplement 7AP
1985-03-25Manufacturing (CMC) · Supplement 5AP
1983-04-22Manufacturing (CMC) · Supplement 2AP
1983-04-22Manufacturing (CMC) · Supplement 1AP
1983-01-11OriginalAP
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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