Assyro AI

Orange Book product · Brand (NDA)

SULFAMYLON

MAFENIDE ACETATE

Brand (NDA)NDA 019832DISCN MYLAN INSTITUTIONAL
View MAFENIDE ACETATE familyOpen on FDA Orange Book

At a glance

Jun 05, 1998

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 05, 1998

    28 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MAFENIDE ACETATE

Strength

5%

Dosage form

FOR SOLUTION

Route

TOPICAL

TE code

Not listed

Application

NDA 019832

Product number

003

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.

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