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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 080905

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NDA 080905 describes PROMPT PHENYTOIN SODIUM, which is a drug marketed by Ani Pharms and Watson Labs and is included in two NDAs. Additional details are available on the PROMPT PHENYTOIN SODIUM profile page.

The generic ingredient in PROMPT PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Summary for 080905

Tradename:	PROMPT PHENYTOIN SODIUM
Applicant:	Watson Labs
Ingredient:	phenytoin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG PROMPT
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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