Assyro AI

Orange Book product · Brand (NDA)

CERVIDIL

DINOPROSTONE

Brand (NDA)NDA 020411RX FERRING PHARMS INC
View DINOPROSTONE familyOpen on FDA Orange Book

At a glance

Mar 30, 1995

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 30, 1995

    31 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DINOPROSTONE

Strength

10MG

Dosage form

INSERT, EXTENDED RELEASE

Route

VAGINAL

TE code

Not listed

Application

NDA 020411

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

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