Assyro AI

Orange Book product · Generic (ANDA)

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Generic (ANDA)ANDA 079247RX NOVEL LABS INC

At a glance

Dec 30, 2011

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 30, 2011

    14 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Strength

0.398GM;1.102GM

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 079247

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

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.