Orange Book product · Brand (NDA)
CAFERGOT
CAFFEINE; ERGOTAMINE TARTRATE
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
CAFFEINE; ERGOTAMINE TARTRATE
Strength
100MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SUPPOSITORY
Route
RECTAL
TE code
Not listed
Application
NDA 009000
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.
- —CAFERGOTBrand (NDA)
NDA 006620 · NOVARTIS
- 2005ERGOTAMINE TARTRATE AND CAFFEINEGeneric (ANDA)
ANDA 040590 · MIKART
- 2004ERGOTAMINE TARTRATE AND CAFFEINEGeneric (ANDA)
ANDA 040510 · HIKMA INTL PHARMS
- 1983MIGERGOTGeneric (ANDA)
ANDA 086557 · COSETTE
- —CAFERGOTGeneric (ANDA)
ANDA 084294 · CHARTWELL RX
- —WIGRAINEGeneric (ANDA)
ANDA 086562 · ORGANON USA INC
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.
