Viewing data from:

METHYLPREDNISOLONE SODIUM SUCCINATE

ANDA

METHYLPREDNISOLONE SODIUM SUCCINATE | A040583 | FRESENIUS KABI USA LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SOLU-MEDROL(TE code: AP)

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

LUPIN LTDMETHYLPREDNISOLONE SODIUM SUCCINATE

DMF 303752016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 2, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 40MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 30, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 125MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 30, 2004