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Orange Book product · Generic (ANDA)

PILOCARPINE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE

Generic (ANDA)ANDA 212377TE ABRX AUROBINDO PHARMA USA

At a glance

Aug 13, 2019

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 13, 2019

    6 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PILOCARPINE HYDROCHLORIDE

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 212377

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PILOCARPINE HYDROCHLORIDE

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.