GLEOLAN is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Medexus Pharma, Inc.. The primary component is Aminolevulinic Acid Hydrochloride.
Product ID | 59137-231_1e70e08b-337c-42d5-9b37-5c8f6fbcce7e |
NDC | 59137-231 |
Product Type | Human Prescription Drug |
Proprietary Name | GLEOLAN |
Generic Name | Aminolevulinic Acid Hydrochloride |
Dosage Form | Powder, For Solution |
Route of Administration | ORAL |
Marketing Start Date | 2018-04-14 |
Marketing Category | NDA / |
Application Number | NDA208630 |
Labeler Name | Medexus Pharma, Inc. |
Substance Name | AMINOLEVULINIC ACID HYDROCHLORIDE |
Active Ingredient Strength | 1500 mg/1 |
Pharm Classes | Fluorescence Contrast Activity [MoA], Optical Imaging Agent [EPC], Porphyrin Precursor [EPC], Porphyrinogens [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2022-03-01 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
59137-231 | GLEOLAN | AMINOLEVULINIC ACID HYDROCHLORIDE |
71469-231 | GLEOLAN | AMINOLEVULINIC ACID HYDROCHLORIDE |
70621-101 | AMELUZ | aminolevulinic acid hydrochloride |
67308-101 | LEVULAN KERASTICK | aminolevulinic acid hydrochloride |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GLEOLAN 87925599 5852682 Live/Registered |
photonamic GmbH & Co. KG 2018-05-17 |