FDA NDA · NDA020645

AMMONUL

Sponsor: BAUSCH

APPLICATION

NDA020645

TYPE

NDA

ORIGINAL APPROVAL

2005-02-17

LATEST ACTION

2020-12-22

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

AMMONUL · ReferenceDiscontinued

SODIUM BENZOATE 10%, SODIUM PHENYLACETATE 10% (5GM/50ML · SOLUTION · INTRAVENOUS

2020-12-22Labeling · Supplement 12 · standard — Letter ↗AP

2017-01-10Manufacturing (CMC) · Supplement 10 · standardAP

2013-08-07Manufacturing (CMC) · Supplement 9 · priorityAP

2011-06-30Labeling · Supplement 8 · unknown — Label ↗AP

2005-02-17Type 3 - New Dosage Form · Original · priority — Review ↗AP

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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