Orange Book product · Brand (NDA)
VALCHLOR
MECHLORETHAMINE HYDROCHLORIDE
At a glance
Aug 23, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 23, 2013
13 yr ago
Patent 7838564 expires
Listed drug product patent expiration.
Mar 07, 2026
3 mo ago
Patent 8450375 expires
Listed drug product patent expiration.
Mar 07, 2026
3 mo ago
Patent 8501818 expires
Listed drug product patent expiration.
Mar 07, 2026
3 mo ago
Patent 8501819 expires
Listed method-of-use patent (U-1427) expiration.
Mar 07, 2026
3 mo ago
Patent 9382191 expires
Listed drug product patent expiration.
Mar 07, 2026
3 mo ago
Today
Patent 7872050 expires
Listed method-of-use patent (U-1427) expiration.
Jul 08, 2029
in 3 yr 1 mo
Pharmaceutical detail
Active ingredient
MECHLORETHAMINE HYDROCHLORIDE
Strength
EQ 0.016% BASE
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
NDA 202317
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7838564 | Mar 07, 2026 | 3 mo ago | Product |
| 8450375 | Mar 07, 2026 | 3 mo ago | Product |
| 8501818 | Mar 07, 2026 | 3 mo ago | Product |
| 8501819 | Mar 07, 2026 | 3 mo ago | U-1427 |
| 9382191 | Mar 07, 2026 | 3 mo ago | Product |
| 7872050 | Jul 08, 2029 | in 3 yr 1 mo | U-1427 |
