Assyro AI

Orange Book product · Generic (ANDA)

BLEOMYCIN SULFATE

BLEOMYCIN SULFATE

Generic (ANDA)ANDA 065042TE APRX HIKMA

At a glance

Oct 17, 2001

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 17, 2001

    25 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

BLEOMYCIN SULFATE

Strength

EQ 15 UNITS BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 065042

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BLEOMYCIN SULFATE

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.