Assyro AI

Orange Book product · Brand (NDA)

MIACALCIN

CALCITONIN SALMON

Brand (NDA)NDA 017808TE APRX MYLAN IRELAND LTD
View CALCITONIN SALMON familyOpen on FDA Orange Book

At a glance

Mar 29, 1991

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 29, 1991

    35 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CALCITONIN SALMON

Strength

200 IU/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

NDA 017808

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.

Book a Demo