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FDA ANDA · ANDA083040

SONAZINE

Sponsor: CHARTWELL RX

APPLICATION
ANDA083040
TYPE
ANDA
ORIGINAL APPROVAL
1976-03-04
LATEST ACTION
2020-02-05
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

SONAZINEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 10MG/5ML · SYRUP · ORAL

Approval history

2020-02-05Labeling · Supplement 44 · standardAP
2017-02-23Labeling · Supplement 43 · standardAP
2012-05-01Labeling · Supplement 42AP
1994-01-24Manufacturing (CMC) · Supplement 41AP
1992-06-04Labeling · Supplement 40AP
1990-06-14Labeling · Supplement 39AP
1989-09-12Labeling · Supplement 35AP
1988-08-04Manufacturing (CMC) · Supplement 33AP
1988-08-04Manufacturing (CMC) · Supplement 34AP
1988-08-04Manufacturing (CMC) · Supplement 32AP
1988-05-19Labeling · Supplement 31AP
1986-05-29Manufacturing (CMC) · Supplement 29AP
1985-02-11Manufacturing (CMC) · Supplement 27AP
1983-07-08Manufacturing (CMC) · Supplement 23AP
1983-06-06Manufacturing (CMC) · Supplement 24AP
1982-06-24Manufacturing (CMC) · Supplement 21AP
1982-05-19Manufacturing (CMC) · Supplement 17AP
1982-05-19Manufacturing (CMC) · Supplement 18AP
1982-05-19Manufacturing (CMC) · Supplement 16AP
1976-03-04OriginalAP
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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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