Orange Book product · Brand (NDA)
GARAMYCIN
GENTAMICIN SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
GENTAMICIN SULFATE
Strength
EQ 0.3% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 050039
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- —GARAMYCINBrand (NDA)
NDA 050505 · SCHERING
- —GARAMYCINBrand (NDA)
NDA 050425 · 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
- 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.
