Orange Book product · Brand (NDA)
MYDCOMBI
PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE
At a glance
May 05, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 05, 2023
3 yr 2 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
May 05, 2026
2 mo ago
Today
Patent 10839960 expires
Listed method-of-use patent (U-3685) expiration.
Jul 15, 2031
in 5 yr 2 mo
Patent 11398306 expires
Listed method-of-use patent (U-3685) expiration.
Jul 15, 2031
in 5 yr 2 mo
Patent 11839487 expires
Listed method-of-use patent (U-3685) expiration.
Jul 15, 2031
in 5 yr 2 mo
Pharmaceutical detail
Active ingredient
PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE
Strength
2.5%;1%
Dosage form
SPRAY, METERED
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 215352
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
May 05, 2026
2 mo ago
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10839960 | Jul 15, 2031 | in 5 yr 2 mo | U-3685 |
| 11398306 | Jul 15, 2031 | in 5 yr 2 mo | U-3685 |
| 11839487 | Jul 15, 2031 | in 5 yr 2 mo | U-3685 |
