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Orange Book product · Generic (ANDA)

CALCIUM GLUCONATE

CALCIUM GLUCONATE

Generic (ANDA)ANDA 216541TE APRX B BRAUN MEDICAL

At a glance

Aug 21, 2023

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 21, 2023

    2 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CALCIUM GLUCONATE

Strength

10GM/100ML (100MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 216541

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

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.