Orange Book product · Brand (NDA)
ALPHAGAN P
BRIMONIDINE TARTRATE
At a glance
Mar 16, 2001
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 16, 2001
25 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
BRIMONIDINE TARTRATE
Strength
0.15%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
NDA 021262
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2024LUMIFY PRESERVATIVE FREEBrand (NDA)
NDA 218424 · BAUSCH AND LOMB INC
- 2017LUMIFYBrand (NDA)
NDA 208144 · BAUSCH AND LOMB INC
- 2013MIRVASOBrand (NDA)
NDA 204708 · GALDERMA LABS LP
- 2006QOLIANABrand (NDA)
NDA 021764 · SANDOZ
- 2005ALPHAGAN PBrand (NDA)
NDA 021770 · ABBVIE
- 1997ALPHAGANBrand (NDA)
NDA 020490 · ALLERGAN
- 1996ALPHAGANBrand (NDA)
NDA 020613 · ALLERGAN
- 2026BRIMONIDINE TARTRATEGeneric (ANDA)
ANDA 218558 · MICRO LABS
- 2026BRIMONIDINE TARTRATEGeneric (ANDA)
ANDA 220398 · MANKIND PHARMA
- 2026BRIMONIDINE TARTRATEGeneric (ANDA)
ANDA 219219 · GLAND
- 2025BRIMONIDINE TARTRATEGeneric (ANDA)
ANDA 217599 · UPSHER SMITH LABS
- 2024BRIMONIDINE TARTRATEGeneric (ANDA)
ANDA 213215 · LUPIN
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.
