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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.

BENZEDRINE

ANDA

Tentative Approval

AMPHETAMINE SULFATE | A083900 | SMITH KLINE & FRENCH

API Supply Chain7 active DMFs1 inactive

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

VERANOVA LPAMPHETAMINE SULFATE

DMF 150892000

CAMBREX CHARLES CITY INCAMPHETAMINE SULFATE

DMF 153082001

SPECGX LLCAMPHETAMINE SULFATE

DMF 154252001

CURIA NEW YORK INCAMPHETAMINE SULFATE USP

DMF 160192002

VERANOVA LPAMPHETAMINE SULFATE USP (PROCESS II)

DMF 240482010

SIEGFRIED USA LLCAMPHETAMINE SULFATE

DMF 296012016

CHATTEM CHEMICALS INCAMPHETAMINE SULFATE USP

DMF 332332018

ISP FREETOWN FINE CHEMICALS INCInactiveAMPHETAMINE SULFATE

DMF 156062001

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

Products (2)

Sort:

#001 — 5MG

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Tablet; Oral | Approved: 1976-02-26 00:00:00

No patent or exclusivity listings for this strength.

#002 — 10MG

▾

Tablet; Oral | Approved: 1976-02-26 00:00:00