VALCHLOR is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Helsinn Therapeutics (u.s.), Inc.. The primary component is Mechlorethamine.
Product ID | 69639-120_15ed0eaf-4b85-45a9-b919-091487a338ac |
NDC | 69639-120 |
Product Type | Human Prescription Drug |
Proprietary Name | VALCHLOR |
Generic Name | Mechlorethamine Hydrochloride |
Dosage Form | Gel |
Route of Administration | TOPICAL |
Marketing Start Date | 2018-11-08 |
Marketing Category | NDA / NDA |
Application Number | NDA202317 |
Labeler Name | Helsinn Therapeutics (U.S.), Inc. |
Substance Name | MECHLORETHAMINE |
Active Ingredient Strength | 0 g/60g |
Pharm Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2018-11-08 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA202317 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | GM |
Marketing Start Date | 2018-11-08 |
Ingredient | Strength |
---|---|
MECHLORETHAMINE | .012 g/60g |
SPL SET ID: | 6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
66215-016 | VALCHLOR | mechlorethamine hydrochloride |
69639-120 | VALCHLOR | mechlorethamine hydrochloride |
55292-911 | Mustargen | mechlorethamine hydrochloride |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VALCHLOR 85425856 4538181 Live/Registered |
HELSINN BIREX PHARMACEUTICALS LIMITED 2011-09-19 |