Orange Book product · Generic (ANDA)
GYNE-SULF
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)
At a glance
Jun 09, 1986
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 09, 1986
40 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)
Strength
3.7%;2.86%;3.42%
Dosage form
CREAM
Route
VAGINAL
TE code
Not listed
Application
ANDA 088607
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)
- —SULTRINBrand (NDA)
NDA 005794 · ORTHO MCNEIL PHARM
- 1987VAGILIAGeneric (ANDA)
ANDA 088821 · COSETTE
- 1985TRIPLE SULFAGeneric (ANDA)
ANDA 088463 · FOUGERA
- 1985TRIPLE SULFAGeneric (ANDA)
ANDA 088462 · PHARMADERM
- 1982TRIPLE SULFAGeneric (ANDA)
ANDA 087285 · PADAGIS US
- 1982TRIPLE SULFAGeneric (ANDA)
ANDA 087864 · ALPHARMA US PHARMS
- 1982TRYSULGeneric (ANDA)
ANDA 087887 · SAVAGE LABS
- —TRIPLE SULFAGeneric (ANDA)
ANDA 086424 · FOUGERA
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.
