FDA Orange Book · active-ingredient family
Caffeine; ergotamine tartrate
Caffeine; ergotamine tartrate is approved as 2 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CAFERGOT · NDA 009000
2
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suppository, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAFERGOTRLD | NOVARTIS | NDA 009000 | — | Approved Prior to Jan 1, 1982 | |
| CAFERGOT | NOVARTIS | NDA 006620 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERGOTAMINE TARTRATE AND CAFFEINE | MIKART | ANDA 040590 | — | Sep 16, 2005 | |
| ERGOTAMINE TARTRATE AND CAFFEINE | HIKMA INTL PHARMS | ANDA 040510 | — | Sep 17, 2004 | |
| MIGERGOTRLD | COSETTE | ANDA 086557 | — | Oct 04, 1983 | |
| CAFERGOTRLD | CHARTWELL RX | ANDA 084294 | — | Approved Prior to Jan 1, 1982 | |
| WIGRAINE | ORGANON USA INC | ANDA 086562 | — | Approved Prior to Jan 1, 1982 |
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.
Caffeine; ergotamine tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
