NDC 0462-0269
Temovate Scalp Application
Clobetasol Propionate
Temovate Scalp Application is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaderm, A Division Of Fougera Pharmaceuticals Inc.. The primary component is Clobetasol Propionate.
| Product ID | 0462-0269_20bdd08b-0d3d-4ad0-8da8-179111d45ecd |
| NDC | 0462-0269 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Temovate Scalp Application |
| Generic Name | Clobetasol Propionate |
| Dosage Form | Solution |
| Route of Administration | TOPICAL |
| Marketing Start Date | 1990-02-22 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019966 |
| Labeler Name | PharmaDerm, A division of Fougera Pharmaceuticals Inc. |
| Substance Name | CLOBETASOL PROPIONATE |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 0462-0269-50
50 mL in 1 BOTTLE, PLASTIC (0462-0269-50)
| Marketing Start Date | 1990-02-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0462-0269-50 [00462026950]
Temovate Scalp Application SOLUTION
| Marketing Category | NDA |
| Application Number | NDA019966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1990-02-22 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CLOBETASOL PROPIONATE | .5 mg/mL |
OpenFDA Data
| SPL SET ID: | b269d3ad-fbae-4ef9-8b3e-e0477ab4615a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Corticosteroid [EPC]
- Corticosteroid Hormone Receptor Agonists [MoA]
NDC Crossover Matching brand name "Temovate Scalp Application" or generic name "Clobetasol Propionate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0168-0162 | Clobetasol Propionate | clobetasol propionate |
| 0168-0163 | Clobetasol Propionate | clobetasol propionate |
| 0168-0269 | Clobetasol Propionate | Clobetasol Propionate |
| 0168-0293 | Clobetasol Propionate | clobetasol propionate |
| 0378-8055 | Clobetasol Propionate | Clobetasol Propionate |
| 0378-8167 | clobetasol propionate | clobetasol propionate |
| 0378-8190 | Clobetasol Propionate | Clobetasol Propionate |
| 0472-0400 | Clobetasol Propionate | Clobetasol Propionate |
| 0472-0402 | Clobetasol Propionate | Clobetasol Propionate |
| 0472-0403 | Clobetasol Propionate | Clobetasol Propionate |
| 0472-0404 | Clobetasol Propionate | Clobetasol Propionate |
| 0574-2063 | Clobetasol Propionate | CLOBETASOL PROPIONATE |
| 0574-2103 | Clobetasol Propionate | Clobetasol Propionate |
| 0168-0301 | Clobetasol Propionate (emollient) | clobetasol propionate |
| 0299-3847 | Clobex | clobetasol propionate |
| 0299-3848 | Clobex | Clobetasol Propionate |
| 0299-3849 | CLOBEX | clobetasol propionate |
| 0378-8182 | OLUX | clobetasol propionate |
| 0378-8147 | OLUX-E | clobetasol propionate |
| 0462-0269 | Temovate | Clobetasol Propionate |
| 0462-0293 | Temovate | clobetasol propionate |
Trademark Results [Temovate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TEMOVATE 73585431 1428974 Live/Registered |
GLAXO GROUP LIMITED 1986-03-03 |
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