Assyro AI

Orange Book product · Brand (NDA)

DRISDOL

ERGOCALCIFEROL

Brand (NDA)NDA 003444TE AARX ESJAY PHARMA

At a glance

Approved Prior to Jan 1, 1982

Approved

Brand (NDA)

Application

AA

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

ERGOCALCIFEROL

Strength

50,000 IU

Dosage form

CAPSULE

Route

ORAL

TE code

AA

Application

NDA 003444

Product number

001

Marketing status

RX

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.

Agent CTA Background

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