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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.

GALANTAMINE HYDROBROMIDE

ANDATentative Approval

GALANTAMINE HYDROBROMIDE | A077592 | SUN PHARM INDS

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.

Products (3)

Sort:

#001 — 4MG

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TABLET; ORAL | TA Date: Aug. 28, 2007

No patent or exclusivity listings for this strength.

#002 — 8MG

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TABLET; ORAL | TA Date: Aug. 28, 2007

#003 — 12MG

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TABLET; ORAL | TA Date: Aug. 28, 2007