Assyro AI

Orange Book product · Generic (ANDA)

FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Generic (ANDA)ANDA 077355OTC PERRIGO R AND D

At a glance

Feb 06, 2008

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 06, 2008

    18 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Strength

800MG;10MG;165MG

Dosage form

TABLET, CHEWABLE

Route

ORAL

TE code

Not listed

Application

ANDA 077355

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

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.