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FDA Approval

Mycophenolic Acid

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Major Pharmaceuticals
DUNS: 191427277
Effective Date
June 3, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Mycophenolic acid(360 mg in 1 1)

Products2

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

Mycophenolic Acid

Product Details

NDC Product Code
0904-6786
Application Number
ANDA091558
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 3, 2022
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
Polyethylene Glycol 8000Inactive
Code: Q662QK8M3BClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Mycophenolic acidActive
Code: WX877SQI1GClass: ACTIMQuantity: 360 mg in 1 1
METHYLCELLULOSE (400 MPA.S)Inactive
Code: O0GN6F9B2YClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Mycophenolic Acid

Product Details

NDC Product Code
0904-6785
Application Number
ANDA091558
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 3, 2022
Mycophenolic acidActive
Code: WX877SQI1GClass: ACTIMQuantity: 180 mg in 1 1
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Polyethylene Glycol 8000Inactive
Code: Q662QK8M3BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
METHYLCELLULOSE (400 MPA.S)Inactive
Code: O0GN6F9B2YClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
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