Orange Book product · Brand (NDA)
DAPTOMYCIN
DAPTOMYCIN
At a glance
Sep 12, 2017
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 12, 2017
8 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
DAPTOMYCIN
Strength
350MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
NDA 208385
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 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
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.
