Orange Book product · Brand (NDA)
RAYOS
PREDNISONE
At a glance
Jul 26, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 26, 2012
14 yr 1 mo ago
Today
Patent 9504699 expires
Listed method-of-use patent (U-1362) expiration.
Aug 03, 2027
in 1 yr 2 mo
Pharmaceutical detail
Active ingredient
PREDNISONE
Strength
1MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 202020
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —DELTASONEBrand (NDA)
NDA 009986 · PHARMACIA AND UPJOHN
- —METICORTENBrand (NDA)
NDA 009766 · SCHERING
- —PARACORTBrand (NDA)
NDA 010962 · PARKE DAVIS
- 2025PREDNISONEGeneric (ANDA)
ANDA 219477 · DR REDDYS
- 2022PREDNISONEGeneric (ANDA)
ANDA 215672 · AUROBINDO PHARMA LTD
- 2021PREDNISONEGeneric (ANDA)
ANDA 215671 · AUROBINDO PHARMA LTD
- 2020PREDNISONEGeneric (ANDA)
ANDA 213386 · AMNEAL
- 2020PREDNISONEGeneric (ANDA)
ANDA 213385 · AMNEAL
- 2018PREDNISONEGeneric (ANDA)
ANDA 211496 · GENEYORK PHARMS
- 2018PREDNISONEGeneric (ANDA)
ANDA 210525 · GENEYORK PHARMS
- 2017PREDNISONEGeneric (ANDA)
ANDA 204867 · ACTAVIS LABS FL INC
- 2010PREDNISONEGeneric (ANDA)
ANDA 040890 · HIKMA PHARMS
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9504699 | Aug 03, 2027 | in 1 yr 2 mo | U-1362 |

