Orange Book product · Brand (NDA)
DAPZURA RT
DAPTOMYCIN
At a glance
Jan 25, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 25, 2022
4 yr 6 mo ago
Today
Patent 11173189 expires
Listed drug product patent expiration.
Mar 11, 2041
in 14 yr 11 mo
Pharmaceutical detail
Active ingredient
DAPTOMYCIN
Strength
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 213645
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.
- 2024DAPTOMYCINBrand (NDA)
NDA 217630 · MAIA PHARMS INC
- 2023DAPTOMYCINBrand (NDA)
NDA 217415 · HIKMA
- 2021DAPTOMYCINBrand (NDA)
NDA 210282 · HOSPIRA
- 2017DAPTOMYCINBrand (NDA)
NDA 209949 · HIKMA
- 2017DAPTOMYCINBrand (NDA)
NDA 208385 · SAGENT PHARMS INC
- 2003CUBICINBrand (NDA)
NDA 021572 · CUBIST PHARMS LLC
- 2024DAPTOMYCINGeneric (ANDA)
ANDA 217215 · BIOCON PHARMA
- 2024DAPTOMYCINGeneric (ANDA)
ANDA 213396 · FRESENIUS KABI USA
- 2023DAPTOMYCINGeneric (ANDA)
ANDA 213966 · MYLAN
- 2022DAPTOMYCINGeneric (ANDA)
ANDA 216445 · ASPIRO
- 2022DAPTOMYCINGeneric (ANDA)
ANDA 216413 · ASPIRO
- 2022DAPTOMYCINGeneric (ANDA)
ANDA 215890 · HAINAN POLY PHARM
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11173189 | Mar 11, 2041 | in 14 yr 11 mo | ProductU-3294 |
