FDA Orange Book · active-ingredient family
Nicotine
Nicotine is approved as 6 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HABITROL · NDA 020076
6
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, extended release, inhalant, spray, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HABITROLRLD×3 | DR REDDYS LABS SA | NDA 020076 | — | Nov 12, 1999 | |
| NICOTROLRLD | PFIZER | NDA 020714 | — | May 02, 1997 | |
| NICODERM CQRLD×3 | CHATTEM SANOFI | NDA 020165 | — | Aug 02, 1996 | |
| NICOTROLRLD | PFIZER INC | NDA 020385 | — | Mar 22, 1996 | |
| PROSTEP×2 | AVEVA | NDA 019983 | — | Dec 23, 1998 | |
| NICOTROL | MCNEIL CONS | NDA 020536 | — | Jul 03, 1996 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NICOTINE×3 | DIFGEN PHARMS | ANDA 074612 | — | Jul 28, 2003 |
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.
Nicotine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
