FDA NDA · NDA016097

MINTEZOL

Sponsor: MERCK SHARP DOHME

APPLICATION

NDA016097

TYPE

NDA

ORIGINAL APPROVAL

1967-04-21

LATEST ACTION

2003-06-11

ROUTE

ORAL

DOSAGE FORM

SUSPENSION

MARKETING STATUS

Discontinued

Products

MINTEZOLDiscontinued

THIABENDAZOLE 500MG/5ML · SUSPENSION · ORAL

2003-06-11Labeling · Supplement 26 · standard — Label ↗AP

2002-10-24Manufacturing (CMC) · Supplement 25 · standardAP

2001-06-29Labeling · Supplement 24 · standard — Letter ↗AP

1996-06-03Labeling · Supplement 23AP

1990-04-04Manufacturing (CMC) · Supplement 22 · standardAP

1987-04-06Labeling · Supplement 18AP

1985-10-18Labeling · Supplement 21AP

1985-04-01Labeling · Supplement 17AP

1985-01-23Manufacturing (CMC) · Supplement 20 · standardAP

1983-11-09Labeling · Supplement 15AP

1978-04-17Labeling · Supplement 13AP

1977-05-03Labeling · Supplement 12AP

1976-09-09Labeling · Supplement 11AP

1976-06-24Manufacturing (CMC) · Supplement 10 · standardAP

1975-10-30Labeling · Supplement 9AP

1975-02-21Manufacturing (CMC) · Supplement 8 · standardAP

1967-04-21Type 3 - New Dosage Form · Original · standardAP

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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