Assyro AI

Orange Book product · Generic (ANDA)

ACETYLCYSTEINE

ACETYLCYSTEINE

Generic (ANDA)ANDA 072323DISCN ROXANE
View ACETYLCYSTEINE familyOpen on FDA Orange Book

At a glance

Apr 30, 1992

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 30, 1992

    34 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ACETYLCYSTEINE

Strength

10%

Dosage form

SOLUTION

Route

INHALATION, ORAL

TE code

Not listed

Application

ANDA 072323

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ACETYLCYSTEINE

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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