FDA Orange Book · active-ingredient family
Methylprednisolone
Methylprednisolone is approved as 1 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MEDROL · NDA 011153
1
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEDROLRLD×6 | PFIZER | NDA 011153 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHYLPREDNISOLONE×4 | AMNEAL | ANDA 207481 | — | Sep 21, 2021 | |
| METHYLPREDNISOLONE | PRAXGEN | ANDA 212262 | — | Jun 27, 2019 | |
| METHYLPREDNISOLONE×5 | CHARTWELL RX | ANDA 209097 | — | Feb 22, 2019 | |
| METHYLPREDNISOLONE | INGENUS PHARMS LLC | ANDA 210985 | — | Jan 09, 2019 | |
| METHYLPREDNISOLONE | TIANJIN TIANYAO | ANDA 204072 | AB | May 14, 2018 | |
| METHYLPREDNISOLONE×4 | ZYDUS PHARMS | ANDA 206751 | AB | Apr 23, 2018 | |
| METHYLPREDNISOLONE | PH HEALTH | ANDA 040183 | AB | Dec 22, 1998 | |
| METHYLPREDNISOLONE×4 | JUBILANT CADISTA | ANDA 040189 | AB | Oct 31, 1997 | |
| METHYLPREDNISOLONE | SANDOZ | ANDA 040194 | AB | Oct 31, 1997 | |
| METHYLPREDNISOLONE | WATSON LABS | ANDA 040232 | AB | Oct 16, 1997 | |
| METHYLPREDNISOLONE | PAR PHARM | ANDA 089207 | — | Apr 25, 1988 | |
| METHYLPREDNISOLONE | PAR PHARM | ANDA 089208 | — | Apr 25, 1988 | |
| METHYLPREDNISOLONE | PAR PHARM | ANDA 089209 | — | Apr 25, 1988 | |
| METHYLPREDNISOLONE | DURAMED PHARMS BARR | ANDA 088497 | — | Feb 21, 1984 | |
| METHYLPREDNISOLONE | WATSON LABS | ANDA 086161 | — | Feb 09, 1982 | |
| METHYLPREDNISOLONE | WATSON LABS | ANDA 086159 | — | Feb 09, 1982 | |
| METHYLPREDNISOLONE | HEATHER | ANDA 085650 | — | Approved Prior to Jan 1, 1982 | |
| METHYLPREDNISOLONE | RISING | ANDA 087341 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Methylprednisolone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
