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Orange Book product · Generic (ANDA)

PHENYTOIN SODIUM

PHENYTOIN SODIUM

Generic (ANDA)ANDA 084307TE APRX HIKMA
View PHENYTOIN SODIUM familyOpen on FDA Orange Book

At a glance

Approved Prior to Jan 1, 1982

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

PHENYTOIN SODIUM

Strength

50MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 084307

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of PHENYTOIN SODIUM

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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