Assyro AI

Orange Book product · Brand (NDA)

CHEMET

SUCCIMER

Brand (NDA)NDA 019998RX RECORDATI RARE

At a glance

Jan 30, 1991

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 30, 1991

    35 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SUCCIMER

Strength

100MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 019998

Product number

002

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.