FDA NDA · NDA010155

MYTELASE

Sponsor: SANOFI AVENTIS US

APPLICATION

NDA010155

TYPE

NDA

ORIGINAL APPROVAL

1956-05-01

LATEST ACTION

2014-11-26

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

MYTELASEDiscontinued

AMBENONIUM CHLORIDE 10MG · TABLET · ORAL

2014-11-26Labeling · Supplement 24 · standard — Label ↗AP

2011-11-14Labeling · Supplement 22 · standard — Letter ↗AP

2011-11-14Labeling · Supplement 23 · standard — Label ↗AP

2003-02-26Labeling · Supplement 21 · standard — Letter ↗AP

2002-03-27Manufacturing (CMC) · Supplement 20 · standardAP

1991-12-02Manufacturing (CMC) · Supplement 18 · standardAP

1991-12-02Manufacturing (CMC) · Supplement 19 · standardAP

1990-03-09Manufacturing (CMC) · Supplement 17 · standardAP

1986-01-03Labeling · Supplement 15AP

1982-04-01Manufacturing (CMC) · Supplement 13 · standardAP

1981-04-20Manufacturing (CMC) · Supplement 12 · standardAP

1981-02-18Manufacturing (CMC) · Supplement 11 · standardAP

1980-04-02Labeling · Supplement 10AP

1980-02-06Manufacturing (CMC) · Supplement 9 · standardAP

1977-12-20Labeling · Supplement 7AP

1977-12-20Labeling · Supplement 8AP

1956-05-01Type 1 - New Molecular Entity · 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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