APPLICATION
ANDA062421
TYPE
ANDA
ORIGINAL APPROVAL
1983-02-02
LATEST ACTION
2025-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 100MG BASE · TABLET · ORAL
Approval history
2025-08-11Labeling · Supplement 76 · standardAP
2025-03-31Labeling · Supplement 75 · standardAP
2021-05-17Labeling · Supplement 70 · standardAP
2021-05-17Labeling · Supplement 69 · standardAP
2018-01-02Labeling · Supplement 68 · standardAP
2018-01-02Labeling · Supplement 62 · standardAP
2018-01-02Labeling · Supplement 67 · standardAP
2012-12-14Labeling · Supplement 60 · standardAP
2010-07-28Labeling · Supplement 52AP
2005-09-01Labeling · Supplement 32AP
2003-04-18Labeling · Supplement 27AP
2002-12-23Labeling · Supplement 28AP
2001-05-01Manufacturing (CMC) · Supplement 25AP
2001-04-25Manufacturing (CMC) · Supplement 26AP
2000-12-26Manufacturing (CMC) · Supplement 24AP
2000-08-09Labeling · Supplement 23AP
1993-09-01Labeling · Supplement 21AP
1993-04-14Labeling · Supplement 20AP
1992-10-23Labeling · Supplement 19AP
1992-02-26Labeling · Supplement 18AP
1991-05-31Manufacturing (CMC) · Supplement 16AP
1990-11-15Manufacturing (CMC) · Supplement 17AP
1990-06-29Manufacturing (CMC) · Supplement 15AP
1988-10-14Manufacturing (CMC) · Supplement 13AP
1988-09-01Manufacturing (CMC) · Supplement 12AP
1983-02-02OriginalAP
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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