Orange Book product · Brand (NDA)

UNASYN

AMPICILLIN SODIUM; SULBACTAM SODIUM

Brand (NDA)NDA 050608TE APRX PFIZER

View AMPICILLIN SODIUM; SULBACTAM SODIUM family Open on FDA Orange Book

At a glance

Dec 10, 1993

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 10, 1993
33 yr ago
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

Application

NDA 050608

Product number

005

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.

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