Assyro AI

Orange Book product · Generic (ANDA)

GENTAMICIN SULFATE

GENTAMICIN SULFATE

Generic (ANDA)ANDA 062351TE ATRX PADAGIS US
View GENTAMICIN SULFATE familyOpen on FDA Orange Book

At a glance

Feb 18, 1982

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 18, 1982

    45 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

GENTAMICIN SULFATE

Strength

EQ 0.1% BASE

Dosage form

OINTMENT

Route

TOPICAL

TE code

AT

Application

ANDA 062351

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of GENTAMICIN 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

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