Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203575
Company: PAR STERILE PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/28/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203575Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/21/2021 SUPPL-6 REMS - MODIFIED - D-N-A

Label is not available on this site.

01/15/2021 SUPPL-4 REMS - MODIFIED - D-N-A

Label is not available on this site.

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELLCEPT MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 050758 ROCHE PALO
MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 204043 AKORN
MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 211374 AMNEAL
MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 212130 MEITHEAL
MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 203859 MYLAN LABS LTD
MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 203575 PAR STERILE PRODUCTS
MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 204473 ZYDUS PHARMS

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