Orange Book product · Generic (ANDA)
GENOPTIC
GENTAMICIN SULFATE
At a glance
Oct 10, 1984
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 10, 1984
42 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
GENTAMICIN SULFATE
Strength
EQ 0.3% BASE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 062452
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.
