TOLAK is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Hill Dermaceuticals, Inc.. The primary component is Fluorouracil.
| Product ID | 28105-421_61b1343b-cc88-4960-a4a2-ce170b3cd3ea |
| NDC | 28105-421 |
| Product Type | Human Prescription Drug |
| Proprietary Name | TOLAK |
| Generic Name | Fluorouracil |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2015-09-18 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022259 |
| Labeler Name | HILL DERMACEUTICALS, INC. |
| Substance Name | FLUOROURACIL |
| Active Ingredient Strength | 0 g/g |
| Pharm Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2015-09-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA022259 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2015-09-18 |
| Ingredient | Strength |
|---|---|
| FLUOROURACIL | .04 g/g |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 64370-421 | TOLAK | TOLAK |
| 28105-421 | TOLAK | TOLAK |
| 0703-3015 | Adrucil | Fluorouracil |
| 0703-3018 | Adrucil | Fluorouracil |
| 0703-3019 | Adrucil | Fluorouracil |
| 0187-5200 | Carac | fluorouracil |
| 0187-3204 | Efudex | Fluorouracil |
| 16110-812 | Fluoroplex | fluorouracil |
| 0378-4791 | Fluorouracil | Fluorouracil |
| 16714-178 | Fluorouracil | Fluorouracil |
| 16729-276 | Fluorouracil | Fluorouracil |
| 16729-542 | Fluorouracil | Fluorouracil |
| 21695-829 | FLUOROURACIL | fluorouracil |
| 25021-215 | fluorouracil | fluorouracil |
| 0378-8078 | Fluorouracil Cream | fluorouracil |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TOLAK 85529383 4818184 Live/Registered |
Hill Dermaceuticals, Inc. 2012-01-31 |
![]() TOLAK 77464979 not registered Dead/Abandoned |
Hill Dermaceuticals, Inc. 2008-05-02 |