Viewing data from:

LEVORPHANOL TARTRATE

ANDA

LEVORPHANOL TARTRATE | A211484 | ACERTIS PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs3 inactive

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

SPECGX LLCLEVORPHANOL TARTRATE USP SPECIAL

DMF 188232005

NOVITIUM PHARMA LLCLEVORPHANOL TARTRATE USP

DMF 332242018

AMPAC FINE CHEMICALS LLCLEVORPHANOL TARTRATE DRUG SUBSTANCE

DMF 343042020

NORAMCO LLCLEVORPHANOL TARTRATE

DMF 359772021

HOFFMANN LA ROCHE INCInactiveLEVORPHANOL TARTRATE AMPULES, 5ML,0.25MG/ML MNFG.IN NEW JERSEY FACIL.

DMF 37261980

MALLINCKRODT PHARMS DIV MALLINCKRODT INCInactiveLEVORPHANOL TARTRATE

DMF 76251988

MALLINCKRODT INCInactiveLEVORPHANOL TARTRATE

DMF 99681992

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 18, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 13, 2018

No patent or exclusivity listings for this strength.