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DEXMETHYLPHENIDATE HYDROCHLORIDE

ANDA

DEXMETHYLPHENIDATE HYDROCHLORIDE | A079108 | IMPAX LABORATORIES INC

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FOCALIN XR(TE code: AB)

API Supply Chain6 active DMFs

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

SIEGFRIED USA LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 132281998

LONZA INCDEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL)

DMF 171172004

CURIA MISSOURI INCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 203852007

PURISYS LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 294112016

SPECGX LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 306572016

ALKEM LABORATORIES LTDDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 329022018

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 5, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

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#001 — 5MG

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 5, 2015

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 5, 2015

#003 — 15MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 19, 2014

#004 — 20MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Dec 21, 2015

#005 — 30MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Nov 21, 2013