Orange Book product · Generic (ANDA)
DAPTOMYCIN
DAPTOMYCIN
At a glance
Dec 23, 2022
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 2022
3 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DAPTOMYCIN
Strength
350MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
ANDA 216445
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 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.
