Assyro AI

Orange Book product · Generic (ANDA)

CALCIUM GLUCONATE IN SODIUM CHLORIDE

CALCIUM GLUCONATE

Generic (ANDA)ANDA 217174TE APRX AMNEAL

At a glance

Sep 05, 2023

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 05, 2023

    2 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CALCIUM GLUCONATE

Strength

1GM/50ML (20MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 217174

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of CALCIUM GLUCONATE

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.