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DEXTROAMPHETAMINE SULFATE

ANDA

DEXTROAMPHETAMINE SULFATE | A203901 | ACTAVIS ELIZABETH LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DEXEDRINE SPANSULE(TE code: AB)

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.

Products (3)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Nov 30, 2012

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Nov 30, 2012

#003 — 15MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Nov 30, 2012