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METHYLPREDNISOLONE SODIUM SUCCINATE

ANDA

METHYLPREDNISOLONE SODIUM SUCCINATE | A207549 | AMNEAL EU LTD

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
Dec 6, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 40MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 9, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 125MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Nov 9, 2016