FDA Orange Book · active-ingredient family
Naratriptan hydrochloride
Naratriptan hydrochloride is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AMERGE · NDA 020763
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMERGERLD×2 | GLAXOSMITHKLINE LLC | NDA 020763 | — | Feb 10, 1998 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NARATRIPTAN×2 | AUROBINDO PHARMA USA | ANDA 202431 | — | May 31, 2012 | |
| NARATRIPTAN×2 | ORBION PHARMS | ANDA 091441 | AB | Apr 30, 2012 | |
| NARATRIPTAN×2 | APOTEX CORP | ANDA 091373 | — | Apr 22, 2011 | |
| NARATRIPTAN×2 | HERITAGE | ANDA 200502 | AB | Feb 28, 2011 | |
| NARATRIPTAN | SUN PHARM INDS LTD | ANDA 091552 | — | Feb 14, 2011 | |
| NARATRIPTAN×2 | PADAGIS US | ANDA 091326 | — | Jul 08, 2010 | |
| NARATRIPTAN×2 | ANI PHARMS | ANDA 078751 | — | Jul 07, 2010 | |
| NARATRIPTAN×2 | CHARTWELL RX | ANDA 090288 | — | Jul 07, 2010 | |
| NARATRIPTAN×2 | HIKMA | ANDA 090381 | AB | Jul 07, 2010 |
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.
Naratriptan hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
