APPLICATION
NDA013428
TYPE
NDA
ORIGINAL APPROVAL
1962-11-23
LATEST ACTION
1986-07-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
VALPIN 50Discontinued
ANISOTROPINE METHYLBROMIDE 50MG · TABLET · ORAL
Approval history
1986-07-02Labeling · Supplement 31 · standardAP
1983-09-23Manufacturing (CMC) · Supplement 30 · standardAP
1982-01-11Manufacturing (CMC) · Supplement 29 · standardAP
1979-07-25Manufacturing (CMC) · Supplement 27 · standardAP
1978-10-16Manufacturing (CMC) · Supplement 26 · standardAP
1978-04-17Labeling · Supplement 24 · standardAP
1978-02-21Manufacturing (CMC) · Supplement 25 · standardAP
1976-09-03Efficacy · Supplement 21 · standardAP
1962-11-23Type 3 - New Dosage Form · 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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