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NEOSTIGMINE METHYLSULFATE

ANDA

NEOSTIGMINE METHYLSULFATE | A216291 | DR REDDYS LABORATORIES LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: NEOSTIGMINE METHYLSULFATE(TE code: AP)

API Supply Chain9 active DMFs1 inactive

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

PATHEON AUSTRIA GMBH AND CO KGNEOSTIGMINE METHYLSULFATE

DMF 247602011

EMCURE PHARMACEUTICALS LTDNEOSTIGMINE METHYLSULFATE USP

DMF 283972014

MSN LABORATORIES PRIVATE LTDNEOSTIGMINE METHYLSULFATE USP [ROUTE CODE "NS"]

DMF 291972015

HARMAN FINOCHEM LTDNEOSTIGMINE METHYLSULFATE USP

DMF 301362015

INDOCO REMEDIES LTDNEOSTIGMINE METHYLSULFATE USP

DMF 310032016

ENALTEC LABS PRIVATE LTDNEOSTIGMINE METHYLSULFATE USP

DMF 313872018

GLAND PHARMA LTDNEOSTIGMINE METHYLSULFATE

DMF 321532017

APITORIA PHARMA PRIVATE LTDNEOSTIGMINE METHYLSULFATE USP

DMF 331302018

HUBEI HAOSUN PHARMACEUTICAL CO LTDNEOSTIGMINE METHYLSULFATE

DMF 380872023

HOFFMANN LA ROCHE INCInactiveNEOSTIGMINE METHYLSULFATE

DMF 69411987

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 30, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3MG/3ML (1MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 6, 2022

No patent or exclusivity listings for this strength.