FDA NDA · NDA018523

ACETIC ACID

Sponsor: BAXTER HLTHCARE

APPLICATION

NDA018523

TYPE

NDA

ORIGINAL APPROVAL

1982-02-19

LATEST ACTION

2014-09-26

ROUTE

IRRIGATION, IRRIGATION, URETHRAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

ACETIC ACID 0.25% IN PLASTIC CONTAINERPrescription

ACETIC ACID, GLACIAL 250MG/100ML · SOLUTION · IRRIGATION, URETHRAL

2014-09-26Manufacturing (CMC) · Supplement 22 · standardAP

2011-09-28Manufacturing (CMC) · Supplement 20AP

1999-05-26Labeling · Supplement 15AP

1994-09-30Manufacturing (CMC) · Supplement 12 · standardAP

1993-09-14Manufacturing (CMC) · Supplement 13 · standardAP

1991-11-14Manufacturing (CMC) · Supplement 10 · standardAP

1991-03-26Manufacturing (CMC) · Supplement 11 · standardAP

1990-05-18Manufacturing (CMC) · Supplement 9 · standardAP

1989-07-26Manufacturing (CMC) · Supplement 8 · standardAP

1986-10-30Manufacturing (CMC) · Supplement 7 · standardAP

1985-06-26Labeling · Supplement 6AP

1985-01-24Manufacturing (CMC) · Supplement 2 · standardAP

1984-02-28Manufacturing (CMC) · Supplement 4 · standardAP

1982-02-19Type 5 - New Formulation or New Manufacturer · 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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