Orange Book product · Brand (NDA)
CUBICIN
DAPTOMYCIN
At a glance
Sep 12, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 12, 2003
23 yr 1 mo ago
Today
Patent 8003673 expires
Listed method-of-use patent (U-1180) expiration.
Sep 04, 2028
in 2 yr 3 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500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 021572
Product number
002
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
- 2022DAPZURA RTBrand (NDA)
NDA 213645 · BAXTER HLTHCARE CORP
- 2021DAPTOMYCINBrand (NDA)
NDA 210282 · HOSPIRA
- 2017DAPTOMYCINBrand (NDA)
NDA 209949 · HIKMA
- 2017DAPTOMYCINBrand (NDA)
NDA 208385 · SAGENT PHARMS INC
- 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 |
|---|---|---|---|
| 8003673 | Sep 04, 2028 | in 2 yr 3 mo | U-1180 |
