Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011757
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | AB | Yes | No |
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | 20MG/ML | INJECTABLE;INJECTION | Prescription | AB | Yes | Yes |
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/27/1959 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2023 | SUPPL-123 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011757s123lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/011757Orig1s123ltr.pdf | |
| 05/27/2021 | SUPPL-120 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011757s120lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/09866Orig1s115; 11856Orig1s136; 11757Origs120ltr.pdf | |
| 02/11/2021 | SUPPL-119 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011757s119lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/011757Orig1s119ltr.pdf | |
| 07/24/2018 | SUPPL-114 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011757s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011757Orig1s114Ltr.pdf | |
| 03/15/2017 | SUPPL-111 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011757Orig1s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011757Orig1s111ltr.pdf | |
| 09/08/2016 | SUPPL-104 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011757s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011757Orig1s104ltr.pdf | |
| 07/03/2014 | SUPPL-103 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011757s103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011757Orig1s103ltr.pdf | |
| 06/09/2014 | SUPPL-102 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/2013 | SUPPL-98 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/2013 | SUPPL-97 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2009 | SUPPL-86 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf | |
| 04/07/2009 | SUPPL-85 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf | |
| 05/22/2002 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/2000 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1995 | SUPPL-75 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/07/1994 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1993 | SUPPL-70 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/15/1990 | SUPPL-64 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/14/1989 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 05/12/1986 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 01/05/1989 | SUPPL-59 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/09/1983 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 03/09/1983 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 05/12/1986 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 07/29/1980 | SUPPL-54 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/12/1986 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 07/12/1978 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 02/17/1981 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/20/2023 | SUPPL-123 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011757s123lbl.pdf | |
| 05/27/2021 | SUPPL-120 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011757s120lbl.pdf | |
| 02/11/2021 | SUPPL-119 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011757s119lbl.pdf | |
| 07/24/2018 | SUPPL-114 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011757s114lbl.pdf | |
| 03/15/2017 | SUPPL-111 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011757Orig1s111lbl.pdf | |
| 09/08/2016 | SUPPL-104 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011757s104lbl.pdf | |
| 07/03/2014 | SUPPL-103 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011757s103lbl.pdf | |
| 04/07/2009 | SUPPL-86 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf | |
| 04/07/2009 | SUPPL-85 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf |
DEPO-MEDROL
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 | 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 | 214297 | PAR STERILE PRODUCTS |
| 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 | SLAYBACK PHARMA LLC |
INJECTABLE;INJECTION; 20MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | 20MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 011757 | PFIZER |
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 | 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 | 214297 | PAR STERILE PRODUCTS |
| 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 | SLAYBACK PHARMA LLC |