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NDA

GALANTAMINE HYDROBROMIDE | N021224 | JANSSEN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs7 inactive

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

SCINOPHARM TAIWAN LTDGALANTAMINE HYDROBROMIDE USP

DMF 178632004

DR REDDYS LABORATORIES LTDGALANTAMINE HYDROBROMIDE

DMF 180132005

APITORIA PHARMA PRIVATE LTDGALANTAMINE HYDROBROMIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 219342008

JUBILANT BIOSYS LTDGALANTAMINE HYDROBROMIDE

DMF 219892008

SANOCHEMIA PHARMAZEUTIKA AGGALANTAMINE HYDROBROMIDE

DMF 266432012

SCINOPHARM TAIWAN LTDGALANTAMINE

DMF 275642013

JANSSEN PHARMACEUTICA NVInactiveGALANTAMINE HYDROBROMIDE

DMF 144251999

JANSSEN PHARMACEUTICA NVInactiveGALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC)

DMF 153842001

WUHAN SHIJI PHARMACEUTICAL CO LTDInactiveGALANTAMINE HYDROBROMIDE

DMF 179672005

MACFARLAN SMITH LTDInactiveGALANTAMINE HYDROBROMIDE

DMF 180782005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveGALANTAMINE HYDROBROMIDE USP

DMF 181142005

SA AJINOMOTO OMNICHEM NVInactiveGALANTAMINE HYDROBROMIDE

DMF 181522005

JIANGSU SUNNY HEALTH INDUSTRY CO LTDInactiveGALANTAMINE HYDROBROMIDE (NON-STERILE DRUG SUBSTANCE)

DMF 191342006

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2017	SUPPL -30	View Letter (PDF)
Dec 17, 2015	SUPPL -29	View Letter (PDF)
Feb 12, 2015	SUPPL -28	View Letter (PDF)
Jul 2, 2013	SUPPL -22	View Letter (PDF)
Mar 5, 2012	SUPPL -14	View Letter (PDF)
Mar 5, 2012	SUPPL -15	View Letter (PDF)
Mar 5, 2012	SUPPL -25	View Letter (PDF)
May 1, 2006	SUPPL -10	View Letter (PDF)
May 1, 2006	SUPPL -8	View Letter (PDF)
May 1, 2006	SUPPL -12	View Letter (PDF)
May 1, 2006	SUPPL -11	View Letter (PDF)
May 3, 2005	SUPPL -9	View Letter (PDF)
Sep 9, 2003	SUPPL -5	View Letter (PDF)
May 2, 2002	SUPPL -3	View Letter (PDF)
Jun 22, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jun 22, 2001

No patent or exclusivity listings for this strength.