Viewing data from:

Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

METHYLNALTREXONE BROMIDE

ANDA

Tentative Approval

METHYLNALTREXONE BROMIDE | A208038 | US GENERICS, STERILES

API Supply Chain4 active DMFs

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

NORAMCO LLCMETHYLNALTREXONE BROMIDE

DMF 265282012

CHONGQING LAND TOWER PHARMACEUTICAL CO LTDMETHYLNALTREXONE BROMIDE

DMF 301732016

SIEGFRIED GRAFTON INCMETHYLNALTREXONE BROMIDE

DMF 318032020

SUN PHARMACEUTICAL INDUSTRIES LTDMETHYLNALTREXONE BROMIDE USP

DMF 427822025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 2, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 12MG/0.6ML

▴

SOLUTION;SUBCUTANEOUS | TA Date: 2021-08-12 00:00:00

No patent or exclusivity listings for this strength.