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FDA ANDA · ANDA212396

METHYLPREDNISOLONE SODIUM SUCCINATE

Sponsor: TIANJIN KINGYORK

APPLICATION
ANDA212396
TYPE
ANDA
ORIGINAL APPROVAL
2021-04-20
LATEST ACTION
2023-09-18
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

METHYLPREDNISOLONE SODIUM SUCCINATEPrescription
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATEPrescription
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATEPrescription
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATEPrescription
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATEPrescription
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2023-09-18Labeling · Supplement 2 · standardAP
2023-09-18Labeling · Supplement 1 · standardAP
2021-04-20UNKNOWN · Original · standardAP
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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