Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040183
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
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 |
---|---|---|---|---|---|---|---|
12/22/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40183_Methylprednisolone_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40183ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040183_methylprednisolone_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/05/2019 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
04/19/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
03/16/2001 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/31/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/22/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40183_Methylprednisolone_Prntlbl.pdf |
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 |