Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040620
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription AB No No
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription AB 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
10/27/2006 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/040620Orig1s000BioeqR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2020 SUPPL-30 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/09/2020 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

08/09/2020 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

08/09/2020 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

11/30/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

METHYLPREDNISOLONE ACETATE

INJECTABLE;INJECTION; 40MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPO-MEDROL METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription Yes AB 011757 PFIZER
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 210043 AMNEAL
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 201835 SAGENT PHARMS INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 040719 SANDOZ INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 040794 SANDOZ INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 040557 TEVA PHARMS USA
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE;INJECTION Prescription No AB 040620 TEVA PHARMS USA

INJECTABLE;INJECTION; 80MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPO-MEDROL METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription Yes AB 011757 PFIZER
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 210043 AMNEAL
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 201835 SAGENT PHARMS INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 040719 SANDOZ INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 040794 SANDOZ INC
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 040557 TEVA PHARMS USA
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE;INJECTION Prescription No AB 040620 TEVA PHARMS USA

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