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AMPHETAMINE SULFATE

ANDA

AMPHETAMINE SULFATE | A211139 | AMNEAL PHARMACEUTICALS OF NEW YORK LLC

2 strengths0 unique patents0 unique exclusivities

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 26, 2018

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 26, 2018