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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040194
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL 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
10/31/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/040194ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/20/2002 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

10/12/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

10/12/2001 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1999 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

06/23/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

METHYLPREDNISOLONE

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEDROL METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription Yes AB 011153 PFIZER
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040183 ENDO OPERATIONS
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040189 JUBILANT CADISTA
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040194 SANDOZ
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 204072 TIANJIN TIANYAO
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040232 WATSON LABS
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 206751 ZYDUS PHARMS
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