Orange Book product · Brand (NDA)
CUBICIN
DAPTOMYCIN
At a glance
Sep 12, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 12, 2003
23 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DAPTOMYCIN
Strength
250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active 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
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.
