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METHOTREXATE SODIUM

ANDA

METHOTREXATE SODIUM | A040263 | FRESENIUS KABI USA LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: METHOTREXATE SODIUM(TE code: AP)

API Supply Chain4 active DMFs2 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

EXCELLA GMBH AND CO KGMETHOTREXATE SODIUM

DMF 124721997

ALEMBIC PHARMACEUTICALS LTDMETHOTREXATE SODIUM

DMF 362772021

MSN LABORATORIES PRIVATE LTDMETHOTREXATE SODIUM

DMF 426272025

SHILPA PHARMA LIFESCIENCES LTDMETHOTREXATE SODIUM

DMF 427952025

BEN VENUE LABORATORIES INCInactiveMETHOTREXATE SODIUM FOR INJECTION, LYOPHILIZED

DMF 61221985

LACHEMA BRNOInactiveMETHOTREXATE SODIUM

DMF 95261992

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 26, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 26, 1999

No patent or exclusivity listings for this strength.

#002 — EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 26, 1999