FDA NDA · NDA018458

TALACEN

Sponsor: SANOFI AVENTIS US

APPLICATION

NDA018458

TYPE

NDA

ORIGINAL APPROVAL

1982-09-23

LATEST ACTION

2011-06-22

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

TALACENDiscontinued

ACETAMINOPHEN 650MG, PENTAZOCINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL

2011-06-22Labeling · Supplement 16 · standard — Letter ↗AP

2011-03-10Labeling · Supplement 14 · standard — Letter ↗AP

2008-08-07Labeling · Supplement 13 · standard — Letter ↗AP

2003-07-10Labeling · Supplement 12 · standard — Letter ↗AP

2000-10-31Labeling · Supplement 10 · standardAP

2000-03-30Manufacturing (CMC) · Supplement 9 · standardAP

1988-11-10Labeling · Supplement 7 · standardAP

1988-03-02Manufacturing (CMC) · Supplement 8 · standardAP

1987-05-22Labeling · Supplement 6 · standardAP

1987-03-27Labeling · Supplement 5 · standardAP

1985-10-25Labeling · Supplement 4 · standardAP

1985-05-07Labeling · Supplement 3 · standardAP

1984-06-26Labeling · Supplement 2 · standardAP

1984-01-24Labeling · Supplement 1 · standardAP

1982-09-23Type 4 - New Combination · 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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