Orange Book product · Generic (ANDA)
GENTAMICIN SULFATE
GENTAMICIN SULFATE
At a glance
Jan 08, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 08, 2024
2 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
GENTAMICIN SULFATE
Strength
EQ 40MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 215237
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GENTAMICIN SULFATE
- —GARAMYCINBrand (NDA)
NDA 050505 · SCHERING
- —GARAMYCINBrand (NDA)
NDA 050425 · SCHERING
- —GARAMYCINBrand (NDA)
NDA 050039 · SCHERING
- 2024GENTAMICIN SULFATEGeneric (ANDA)
ANDA 215236 · EUGIA PHARMA
- 2018GENTAMICIN SULFATEGeneric (ANDA)
ANDA 209233 · ENCUBE
- 2004GENTAMICIN SULFATEGeneric (ANDA)
ANDA 065024 · FERA PHARMS LLC
- 1995GENTAMICIN SULFATEGeneric (ANDA)
ANDA 064093 · SCIEGEN PHARMS
- 1994GENTAMICIN SULFATEGeneric (ANDA)
ANDA 064056 · COSETTE PHARMS NC
- 1994GENTAMICIN SULFATEGeneric (ANDA)
ANDA 064054 · COSETTE PHARMS NC
- 1991GENTAMICIN SULFATEGeneric (ANDA)
ANDA 063149 · TEVA PARENTERAL
- 1991GENTAMICIN SULFATEGeneric (ANDA)
ANDA 063106 · TEVA PARENTERAL
- 1987GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 062814 · B BRAUN
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.
