Assyro AI

Orange Book product · Generic (ANDA)

AMPICILLIN AND SULBACTAM

AMPICILLIN SODIUM; SULBACTAM SODIUM

Generic (ANDA)ANDA 065403TE APRX ACS DOBFAR
View AMPICILLIN SODIUM; SULBACTAM SODIUM familyOpen on FDA Orange Book

At a glance

Dec 23, 2009

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 23, 2009

    16 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Strength

EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 065403

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AMPICILLIN SODIUM; SULBACTAM SODIUM

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.

Book a Demo