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FDA NDA · NDA050475

GRIS-PEG

Sponsor: BAUSCH

APPLICATION
NDA050475
TYPE
NDA
ORIGINAL APPROVAL
1975-04-16
LATEST ACTION
2016-12-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GRIS-PEG · ReferencePrescription
GRISEOFULVIN, ULTRAMICROSIZE 125MG · TABLET · ORAL
GRIS-PEG · ReferencePrescription
GRISEOFULVIN, ULTRAMICROSIZE 250MG · TABLET · ORAL

Approval history

2016-12-28Manufacturing (CMC) · Supplement 59 — Label ↗AP
2016-04-19Labeling · Supplement 57 · standard — Letter ↗AP
2013-05-08Manufacturing (CMC) · Supplement 56 · standardAP
2010-10-19Labeling · Supplement 54 · standard — Label ↗AP
2007-01-24Labeling · Supplement 53 · standard — Label ↗AP
2003-03-26Labeling · Supplement 46 · standard — Label ↗AP
2002-08-01Manufacturing (CMC) · Supplement 51 · standardAP
2002-06-03Manufacturing (CMC) · Supplement 50 · standardAP
2001-07-02Manufacturing (CMC) · Supplement 49 · standardAP
2000-12-06Manufacturing (CMC) · Supplement 48 · standardAP
1998-04-16Manufacturing (CMC) · Supplement 47 · standardAP
1997-04-07Manufacturing (CMC) · Supplement 45 · standardAP
1988-06-20Manufacturing (CMC) · Supplement 8 · standardAP
1986-09-16Manufacturing (CMC) · Supplement 6 · standardAP
1985-09-16Labeling · Supplement 5AP
1984-10-24Manufacturing (CMC) · Supplement 4 · standardAP
1984-04-24Manufacturing (CMC) · Supplement 3 · standardAP
1983-02-17Manufacturing (CMC) · Supplement 2 · standardAP
1983-01-26Manufacturing (CMC) · Supplement 1 · standardAP
1982-12-21Manufacturing (CMC) · Supplement 43 · standardAP
1982-12-21Manufacturing (CMC) · Supplement 44 · standardAP
1982-06-28Labeling · Supplement 42AP
1982-02-05Manufacturing (CMC) · Supplement 41 · standardAP
1981-07-06Manufacturing (CMC) · Supplement 37 · standardAP
1981-03-05Manufacturing (CMC) · Supplement 34 · standardAP
1981-03-02Manufacturing (CMC) · Supplement 33 · standardAP
1980-11-21Labeling · Supplement 24AP
1980-11-21Labeling · Supplement 31AP
1980-08-13Labeling · Supplement 32AP
1980-01-21Manufacturing (CMC) · Supplement 27 · standardAP
1980-01-04Manufacturing (CMC) · Supplement 29 · standardAP
1980-01-04Manufacturing (CMC) · Supplement 28 · standardAP
1979-04-10Manufacturing (CMC) · Supplement 25 · standardAP
1978-01-17Manufacturing (CMC) · Supplement 22 · standardAP
1977-07-26Labeling · Supplement 21AP
1977-04-20Manufacturing (CMC) · Supplement 20 · standardAP
1976-12-08Manufacturing (CMC) · Supplement 19 · standardAP
1976-11-18Labeling · Supplement 18AP
1976-11-18Manufacturing (CMC) · Supplement 17 · standardAP
1976-10-01Manufacturing (CMC) · Supplement 16 · standardAP
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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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