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FDA ANDA · ANDA086906

METHYLPREDNISOLONE

Sponsor: ELKINS SINN

APPLICATION
ANDA086906
TYPE
ANDA
ORIGINAL APPROVAL
1980-02-15
LATEST ACTION
1988-10-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

METHYLPREDNISOLONEDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONEDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONEDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATEDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

1988-10-04Labeling · Supplement 31AP
1988-07-15Labeling · Supplement 30AP
1988-03-10Manufacturing (CMC) · Supplement 28AP
1988-03-10Manufacturing (CMC) · Supplement 29AP
1987-07-27Manufacturing (CMC) · Supplement 26AP
1987-02-14Manufacturing (CMC) · Supplement 20AP
1986-11-03Manufacturing (CMC) · Supplement 22AP
1986-03-06Manufacturing (CMC) · Supplement 18AP
1984-03-06Manufacturing (CMC) · Supplement 13AP
1983-08-05Manufacturing (CMC) · Supplement 12AP
1983-03-21Manufacturing (CMC) · Supplement 11AP
1983-03-21Manufacturing (CMC) · Supplement 10AP
1982-09-10Manufacturing (CMC) · Supplement 6AP
1980-02-15OriginalAP
VIEW ON DRUGS@FDA ↗

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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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