Assyro AI

Orange Book product · Brand (NDA)

SILVADENE

SILVER SULFADIAZINE

Brand (NDA)NDA 017381TE ABRX KING PHARMS LLC

At a glance

Approved Prior to Jan 1, 1982

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

SILVER SULFADIAZINE

Strength

1%

Dosage form

CREAM

Route

TOPICAL

TE code

AB

Application

NDA 017381

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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.

Agent CTA Background

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