Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040794
Company: SANDOZ
Company: SANDOZ
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 |
---|---|---|---|---|---|---|---|
03/05/2009 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/040794Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/28/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
04/30/2010 | SUPPL-2 | 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 | 216502 | AMNEAL |
METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 214297 | ENDO OPERATIONS |
METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 211930 | EUGIA PHARMA |
METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 040557 | HONG KONG |
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 |
METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 040794 | SANDOZ |
METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 214870 | WILSHIRE PHARMS INC |
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 | 216502 | AMNEAL |
METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 214297 | ENDO OPERATIONS |
METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 211930 | EUGIA PHARMA |
METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 040557 | HONG KONG |
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 |
METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 040794 | SANDOZ |
METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 214870 | WILSHIRE PHARMS INC |