FDA NDA · NDA017970

NOLVADEX

Sponsor: ASTRAZENECA

APPLICATION

NDA017970

TYPE

NDA

ORIGINAL APPROVAL

1977-12-30

LATEST ACTION

2009-03-13

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

NOLVADEX · ReferenceDiscontinued

TAMOXIFEN CITRATE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

NOLVADEX · ReferenceDiscontinued

TAMOXIFEN CITRATE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2009-03-13Labeling · Supplement 28 · standardAP

2009-03-13Efficacy · Supplement 7AP

2009-03-13Labeling · Supplement 26 · standardAP

2009-03-13Labeling · Supplement 16AP

2009-03-13Labeling · Supplement 22AP

2009-03-13Labeling · Supplement 14AP

2009-03-13Labeling · Supplement 12AP

2009-03-13Labeling · Supplement 37 · standard — Label ↗AP

2009-03-13Labeling · Supplement 29 · standardAP

2009-03-13Labeling · Supplement 19AP

2009-03-13Labeling · Supplement 25 · standardAP

2009-03-13Labeling · Supplement 23AP

2009-03-13Labeling · Supplement 44 · standard — Letter ↗AP

2006-03-09Efficacy · Supplement 54 · unknown — Letter ↗AP

2005-03-17Labeling · Supplement 53 · standard — Letter ↗AP

2004-12-14Labeling · Supplement 52 · standard — Review ↗AP

2003-06-10Labeling · Supplement 48 · standard — Label ↗AP

2003-01-30Labeling · Supplement 51 · standard — Letter ↗AP

2002-08-30Labeling · Supplement 50 · standard — Review ↗AP

2002-05-16Labeling · Supplement 49 · standard — Letter ↗AP

2000-12-14Manufacturing (CMC) · Supplement 47 · standardAP

2000-06-29Efficacy · Supplement 46 · priority — Review ↗AP

2000-04-24Manufacturing (CMC) · Supplement 45 · standardAP

1999-04-02Labeling · Supplement 43 · standardAP

1998-10-30Labeling · Supplement 41 · standardAP

1998-10-29Efficacy · Supplement 40 · priority — Letter ↗AP

1998-10-29Efficacy · Supplement 39 · standard — Review ↗AP

1998-06-11Manufacturing (CMC) · Supplement 38 · standardAP

1996-11-15Labeling · Supplement 35 · standardAP

1996-11-04Manufacturing (CMC) · Supplement 36 · standardAP

1996-03-26Labeling · Supplement 34 · standardAP

1996-01-23Labeling · Supplement 32 · standardAP

1996-01-23Labeling · Supplement 33 · standardAP

1996-01-23Labeling · Supplement 31 · standardAP

1995-02-01Labeling · Supplement 30 · standardAP

1994-03-21Efficacy · Supplement 27 · unknownAP

1993-04-01Efficacy · Supplement 24AP

1991-03-14Manufacturing (CMC) · Supplement 21 · standardAP

1990-06-21Efficacy · Supplement 20AP

1989-03-16Efficacy · Supplement 18 — Review ↗AP

VIEW ON DRUGS@FDA ↗

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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Approval history

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