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PRIMIDONE

ANDA

PRIMIDONE | A218366 | CARNEGIE PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MYSOLINE(TE code: AB)

API Supply Chain5 active DMFs2 inactive

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

SIEGFRIED LTDPRIMIDONE

DMF 21991973

DR REDDYS LABORATORIES LTDPRIMIDONE

DMF 200072006

NANTONG JINGHUA PHARMACEUTICAL CO LTDPRIMIDONE

DMF 216022008

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPRIMIDONE

DMF 352022020

RAKS PHARMA PVT LTDPRIMIDONE USP

DMF 407702024

NANTONG GENERAL PHARMACEUTICAL FACTORYInactivePRIMIDONE USP XXII

DMF 84061990

PROVENTUS LIFE SCIENCES PVT LTDInactivePRIMIDONE

DMF 234442010

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

Products (2)

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#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 23, 2024

No patent or exclusivity listings for this strength.

#002 — 250MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 23, 2024