FDA Orange Book · active-ingredient family
Benzonatate
Benzonatate is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TESSALON · NDA 011210
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TESSALONRLD×2 | PFIZER | NDA 011210 | AA | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BENZONATATE×2 | MARKSANS PHARMA | ANDA 220298 | AA | Mar 30, 2026 | |
| BENZONATATE×3 | ASCENT PHARMS INC | ANDA 211518 | AA | Feb 22, 2019 | |
| BENZONATATE×2 | PURACAP PHARM LLC | ANDA 206948 | AA | Dec 19, 2018 | |
| BENZONATATE×3 | CHARTWELL RX | ANDA 210562 | — | Nov 09, 2018 | |
| BENZONATATE×2 | CSPC-NBP PHARM | ANDA 202765 | AA | Aug 25, 2017 | |
| BENZONATATE×2 | ONESOURCE SPECIALTY | ANDA 091133 | AA | Jul 30, 2015 | |
| BENZONATATE×2 | ACELLA | ANDA 091310 | — | Jan 16, 2015 | |
| BENZONATATE×3 | MIKART | ANDA 040851 | — | Nov 09, 2009 | |
| BENZONATATE×2 | SUN PHARM INDS INC | ANDA 040587 | — | Mar 19, 2008 | |
| BENZONATATE×2 | NESHER PHARMS | ANDA 040795 | — | Oct 31, 2007 | |
| BENZONATATE×2 | HERITAGE PHARMS LABS | ANDA 040682 | AA | Jul 30, 2007 | |
| BENZONATATE×2 | ZYDUS PHARMS USA | ANDA 040597 | AA | Jun 08, 2007 | |
| BENZONATATE×3 | THEPHARMANETWORK LLC | ANDA 040627 | AA | Mar 30, 2007 | |
| BENZONATATE×2 | BIONPHARMA | ANDA 081297 | AA | Jan 29, 1993 |
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.
Benzonatate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
