APPLICATION
NDA010971
TYPE
NDA
ORIGINAL APPROVAL
1957-05-31
LATEST ACTION
1996-06-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PMB 200Discontinued
ESTROGENS, CONJUGATED 0.45MG, MEPROBAMATE 200MG · TABLET · ORAL
PMB 400Discontinued
ESTROGENS, CONJUGATED 0.45MG, MEPROBAMATE 400MG · TABLET · ORAL
Approval history
1996-06-27Manufacturing (CMC) · Supplement 48 · standardAP
1995-12-27Manufacturing (CMC) · Supplement 46 · standardAP
1995-09-07Labeling · Supplement 42 · standardAP
1990-02-23Manufacturing (CMC) · Supplement 44 · standardAP
1988-12-20Manufacturing (CMC) · Supplement 43 · standardAP
1987-05-17Manufacturing (CMC) · Supplement 41 · standardAP
1986-04-11Labeling · Supplement 39 · standardAP
1957-05-31Type 4 - New Combination · 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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