Orange Book product · Generic (ANDA)
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
GENTAMICIN SULFATE
At a glance
Aug 28, 1987
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 28, 1987
39 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
GENTAMICIN SULFATE
Strength
EQ 0.8MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 062814
Product number
001
Marketing status
DISCN
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
- 2024GENTAMICIN SULFATEGeneric (ANDA)
ANDA 215237 · 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
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.
