Assyro AI

Orange Book product · Generic (ANDA)

AMPICILLIN TRIHYDRATE

AMPICILLIN/AMPICILLIN TRIHYDRATE

Generic (ANDA)ANDA 064082TE ABRX SANDOZ

At a glance

Aug 29, 1995

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 29, 1995

    31 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Strength

EQ 500MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 064082

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of AMPICILLIN/AMPICILLIN TRIHYDRATE

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.