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FDA ANDA · ANDA080928

PROPANTHELINE BROMIDE

Sponsor: SANDOZ

APPLICATION
ANDA080928
TYPE
ANDA
LATEST ACTION
1984-06-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROPANTHELINE BROMIDEDiscontinued
PROPANTHELINE BROMIDE 15MG · TABLET · ORAL

Approval history

1984-06-01Manufacturing (CMC) · Supplement 64AP
1983-12-12Manufacturing (CMC) · Supplement 47AP
1983-08-01Manufacturing (CMC) · Supplement 62AP
1983-08-01Manufacturing (CMC) · Supplement 63AP
1983-08-01Manufacturing (CMC) · Supplement 61AP
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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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