Orange Book product · Brand (NDA)
BLEPHAMIDE
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
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
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
Strength
0.2%;10%
Dosage form
SUSPENSION
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 012813
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.
- 1984METIMYDBrand (NDA)
NDA 010210 · SCHERING
- 1993CETAPREDGeneric (ANDA)
ANDA 087771 · ALCON
- 1986BLEPHAMIDE S.O.P.Generic (ANDA)
ANDA 087748 · ALLERGAN
- 1985PREDSULFAIR IIGeneric (ANDA)
ANDA 088837 · PHARMAFAIR
- 1984VASOCIDINGeneric (ANDA)
ANDA 088791 · NOVARTIS
- 1983PREDAMIDEGeneric (ANDA)
ANDA 088059 · EPIC PHARMA LLC
- 1983PREDSULFAIRGeneric (ANDA)
ANDA 088007 · PHARMAFAIR
- 1983PREDSULFAIRGeneric (ANDA)
ANDA 088032 · PHARMAFAIR
- 1982SULPHRINGeneric (ANDA)
ANDA 088089 · BAUSCH AND LOMB
- —ISOPTO CETAPREDGeneric (ANDA)
ANDA 087547 · ALCON
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.
