FDA Orange Book · active-ingredient family
Homatropine methylbromide
Homatropine methylbromide is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EQUIPIN | MISSION PHARMA | ANDA 086310 | — | Approved Prior to Jan 1, 1982 | |
| HOMAPIN-10 | MISSION PHARMA | ANDA 086308 | — | Approved Prior to Jan 1, 1982 | |
| HOMAPIN-5 | MISSION PHARMA | ANDA 086309 | — | Approved Prior to Jan 1, 1982 |
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.
Homatropine methylbromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
