Halobetasol Propionate is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.. The primary component is Halobetasol Propionate.
| Product ID | 0168-0356_db5eba0e-781c-4383-ab1f-15c025cf4290 |
| NDC | 0168-0356 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Halobetasol Propionate |
| Generic Name | Halobetasol Propionate |
| Dosage Form | Ointment |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2004-12-16 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA076903 |
| Labeler Name | E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. |
| Substance Name | HALOBETASOL PROPIONATE |
| Active Ingredient Strength | 1 mg/g |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2004-12-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA076903 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2004-12-16 |
| Marketing End Date | 2011-05-31 |
| Marketing Category | ANDA |
| Application Number | ANDA076903 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2004-12-16 |
| Marketing End Date | 2011-08-31 |
| Ingredient | Strength |
|---|---|
| HALOBETASOL PROPIONATE | .5 mg/g |
| SPL SET ID: | dd9e2429-2e28-4f53-9b26-0ebb7f61c5c4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0168-0355 | Halobetasol Propionate | halobetasol propionate |
| 0168-0356 | Halobetasol Propionate | halobetasol propionate |
| 0713-0339 | Halobetasol Propionate | Halobetasol Propionate |
| 0713-0639 | Halobetasol Propionate | Halobetasol Propionate |
| 0713-0640 | Halobetasol Propionate | Halobetasol Propionate |
| 0713-0758 | Halobetasol Propionate | Halobetasol Propionate |
| 42254-250 | Halobetasol Propionate | Halobetasol Propionate |
| 45802-129 | Halobetasol Propionate | Halobetasol Propionate |
| 45802-131 | Halobetasol Propionate | Halobetasol Propionate |
| 51672-1321 | Halobetasol Propionate | Halobetasol Propionate |
| 51672-1322 | Halobetasol Propionate | Halobetasol Propionate |
| 51862-606 | Halobetasol propionate | Halobetasol propionate |
| 52565-073 | Halobetasol Propionate | halobetasol propionate |
| 52959-961 | Halobetasol Propionate | Halobetasol Propionate |
| 55337-606 | Halobetasol propionate | Halobetasol propionate |
| 63629-8664 | Halobetasol Propionate | Halobetasol Propionate |
| 70512-033 | Halobetasol Propionate | Halobetasol Propionate |
| 63739-998 | Halobetasol Propionate | Halobetasol Propionate |
| 70752-119 | Halobetasol Propionate | Halobetasol Propionate |
| 0187-0002 | Bryhali | halobetasol propionate |
| 51862-604 | LEXETTE | Halobetasol propionate |
| 10631-102 | Ultravate | halobetasol propionate |
| 10631-103 | Ultravate | halobetasol propionate |
| 10631-122 | Ultravate | halobetasol propionate |
| 10631-119 | Ultravate X | Halobetasol Propionate |
| 10631-121 | Ultravate X | Halobetasol Propionate |