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DEXMETHYLPHENIDATE HYDROCHLORIDE

ANDA

DEXMETHYLPHENIDATE HYDROCHLORIDE | A206931 | ABHAI LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FOCALIN(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.

Products (3)

Sort:

#001 — 2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 4, 2015

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 4, 2015

#003 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 4, 2015