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Orange Book product · Generic (ANDA)

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Generic (ANDA)ANDA 077063DISCN WATSON LABS TEVA

At a glance

Dec 31, 2007

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 31, 2007

    18 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Strength

EQ 0.083% BASE;0.017%

Dosage form

SOLUTION

Route

INHALATION

TE code

Not listed

Application

ANDA 077063

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

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.