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GALANTAMINE HYDROBROMIDE

ANDA

GALANTAMINE HYDROBROMIDE | A078189 | BARR LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Oct 3, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 8MG BASE

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Sep 15, 2008

No patent or exclusivity listings for this strength.

#002 — EQ 16MG BASE

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Sep 15, 2008

#003 — EQ 24MG BASE

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Sep 15, 2008