FDA Orange Book · active-ingredient family
Galantamine hydrobromide
Galantamine hydrobromide is approved as 3 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RAZADYNE ER · NDA 021615
3
Brand (NDA)
19
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RAZADYNE ERRLD×3 | JANSSEN PHARMS | NDA 021615 | — | Apr 01, 2005 | |
| RAZADYNERLD×3 | JANSSEN PHARMS | NDA 021169 | — | Feb 28, 2001 | |
| RAZADYNE | JANSSEN PHARMS | NDA 021224 | — | Jun 22, 2001 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GALANTAMINE HYDROBROMIDE×3 | AUROBINDO PHARMA | ANDA 204895 | AB | Aug 05, 2016 | |
| GALANTAMINE HYDROBROMIDE×3 | APOTEX INC | ANDA 077781 | — | Sep 27, 2011 | |
| GALANTAMINE HYDROBROMIDE×3 | AUROBINDO PHARMA LTD | ANDA 090957 | AB | Mar 29, 2011 | |
| GALANTAMINE HYDROBROMIDE×3 | ZYDUS PHARMS USA INC | ANDA 078898 | AB | Feb 17, 2011 | |
| GALANTAMINE HYDROBROMIDE×3 | SUN PHARM | ANDA 090178 | AB | Feb 02, 2011 | |
| GALANTAMINE HYDROBROMIDE×3 | PHARMOBEDIENT | ANDA 090900 | — | Jan 24, 2011 | |
| GALANTAMINE HYDROBROMIDE×3 | HERITAGE PHARMA | ANDA 077585 | — | Sep 15, 2009 | |
| GALANTAMINE HYDROBROMIDE×3 | CHARTWELL RX | ANDA 077587 | — | Jul 09, 2009 | |
| GALANTAMINE HYDROBROMIDE×3 | SANDOZ | ANDA 077589 | AB | Jun 22, 2009 | |
| GALANTAMINE HYDROBROMIDE×3 | MYLAN | ANDA 077590 | — | May 29, 2009 | |
| GALANTAMINE HYDROBROMIDE×3 | IMPAX LABS | ANDA 078484 | — | May 27, 2009 | |
| GALANTAMINE HYDROBROMIDE×3 | HIKMA | ANDA 077608 | — | Feb 11, 2009 | |
| GALANTAMINE HYDROBROMIDE×3 | YABAO PHARM | ANDA 077604 | AB | Feb 06, 2009 | |
| GALANTAMINE HYDROBROMIDE | HIKMA | ANDA 078185 | — | Jan 30, 2009 | |
| GALANTAMINE HYDROBROMIDE×3 | WATSON LABS | ANDA 079028 | AB | Dec 15, 2008 | |
| GALANTAMINE HYDROBROMIDE×3 | BARR | ANDA 078189 | AB | Sep 15, 2008 | |
| GALANTAMINE HYDROBROMIDE×3 | SENORES PHARMS | ANDA 077593 | AB | Sep 11, 2008 | |
| GALANTAMINE HYDROBROMIDE×3 | BARR | ANDA 077605 | AB | Aug 28, 2008 | |
| GALANTAMINE HYDROBROMIDE×3 | PHARMOBEDIENT | ANDA 077603 | — | Aug 28, 2008 |
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.
Galantamine hydrobromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
