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DEXTROAMPHETAMINE SULFATE

ANDA

DEXTROAMPHETAMINE SULFATE | A040361 | BARR LABORATORIES INC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs1 inactive

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

VERANOVA LPDEXTROAMPHETAMINE SULFATE

DMF 147832000

CAMBREX CHARLES CITY INCDEXTROAMPHETAMINE SULFATE USP

DMF 153072001

SPECGX LLCDEXTROAMPHETAMINE SULFATE USP

DMF 153852001

CURIA NEW YORK INCDEXTROAMPHETAMINE SULFATE USP

DMF 160212002

VERANOVA LPDEXTROAMPHETAMINE SULFATE USP

DMF 235832010

SIEGFRIED USA LLCDEXTROAMPHETAMINE SULFATE

DMF 296042016

CHATTEM CHEMICALS INCDEXTROAMPHETAMINE SULFATE USP

DMF 312442017

ISP FREETOWN FINE CHEMICALS INCInactiveDEXTROAMPHETAMINE SULFATE

DMF 156072001

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 3, 2014	SUPPL -17	View Letter (PDF)
Jun 2, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 31, 2001

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 31, 2001