Mycophenolic Acid

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Biocon Pharma Limited

DUNS Number

871412155

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Biocon Pharma Limited

Labeler

Biocon Pharma Inc.

Registrant

Biocon Pharma Limited

DUNS Number

871412155

Biocon Limited

Labeler

Biocon Pharma Inc.

Registrant

Biocon Pharma Limited

DUNS Number

650173537

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

70377-040

Application Number

ANDA214630

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 17, 2022

Ingredients

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Povidone K30Inactive

Code: U725QWY32XClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Starch, CornInactive

Code: O8232NY3SJClass: IACT

Anhydrous LactoseInactive

Code: 3SY5LH9PMKClass: IACT

Crospovidone (35 .Mu.M)Inactive

Code: 40UAA97IT9Class: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

Mycophenolic acidActive

Code: WX877SQI1GClass: ACTIMQuantity: 360 mg in 1 1

Ferric Oxide RedInactive

Code: 1K09F3G675Class: IACT

Hypromellose Phthalate (24% Phthalate, 55 Cst)Inactive

Code: 87Y6436BKRClass: IACT