Orange Book product · Generic (ANDA)
DAPTOMYCIN
DAPTOMYCIN
At a glance
Jun 26, 2019
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 26, 2019
7 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DAPTOMYCIN
Strength
500MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
ANDA 212513
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DAPTOMYCIN
- 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
- 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
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.
