FDA Orange Book · active-ingredient family
Scopolamine
Scopolamine is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TRANSDERM SCOP · NDA 017874
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · system
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRANSDERM SCOPRLD | BAXTER HLTHCARE CORP | NDA 017874 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SCOPOLAMINE | AMNEAL | ANDA 218384 | AB | Jun 09, 2025 | |
| SCOPOLAMINE | ZYDUS PHARMS | ANDA 217893 | AB | Aug 29, 2024 | |
| SCOPOLAMINE | RHODES PHARMS | ANDA 215329 | AB | May 06, 2024 | |
| SCOPOLAMINE | ACTAVIS LABS UT INC | ANDA 208769 | AB | Jan 10, 2022 | |
| SCOPOLAMINE | RICONPHARMA LLC | ANDA 212342 | AB | Nov 24, 2020 | |
| SCOPOLAMINE | MYLAN TECHNOLOGIES | ANDA 203753 | AB | Jun 19, 2019 | |
| SCOPOLAMINE | PADAGIS US | ANDA 078830 | AB | Jan 30, 2015 |
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.
Scopolamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
