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FDA NDA · NDA012770

HYDROCORTISONE AND ACETIC ACID

hydrocortisone and acetic acid otic

Sponsor: SAPTALIS PHARMS

APPLICATION
NDA012770
TYPE
NDA
ORIGINAL APPROVAL
1961-06-23
LATEST ACTION
2024-12-03
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

VOSOL HC · ReferencePrescription
ACETIC ACID, GLACIAL 2%, HYDROCORTISONE 1% · SOLUTION/DROPS · OTIC

Approval history

2024-12-03Labeling · Supplement 33 · standard — Letter ↗AP
1997-10-16Manufacturing (CMC) · Supplement 25 · standardAP
1997-07-29Labeling · Supplement 24 · standard — Letter ↗AP
1995-12-21Manufacturing (CMC) · Supplement 22 · standardAP
1990-08-01Manufacturing (CMC) · Supplement 20 · standardAP
1990-08-01Labeling · Supplement 21AP
1988-09-15Manufacturing (CMC) · Supplement 18 · standardAP
1988-09-15Manufacturing (CMC) · Supplement 19 · standardAP
1988-06-29Labeling · Supplement 16AP
1986-08-26Manufacturing (CMC) · Supplement 15 · standardAP
1985-06-24Manufacturing (CMC) · Supplement 14 · standardAP
1984-08-14Labeling · Supplement 10AP
1984-04-05Manufacturing (CMC) · Supplement 13 · standardAP
1983-02-04Manufacturing (CMC) · Supplement 11 · standardAP
1978-12-04Manufacturing (CMC) · Supplement 8 · standardAP
1978-07-25Labeling · Supplement 9AP
1976-04-07Manufacturing (CMC) · Supplement 6 · standardAP
1975-06-02Manufacturing (CMC) · Supplement 5 · standardAP
1974-07-16Supplement · Supplement 4 · standardAP
1961-06-23Type 4 - New Combination · Original · standardAP
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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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