Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211074
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | AB1 | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/15/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLOBETASOL PROPIONATE
CREAM;TOPICAL; 0.05%
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 213291 | ALEOR DERMACEUTICALS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211256 | AMNEAL |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074139 | COSETTE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 212982 | ENCUBE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074392 | FOUGERA PHARMS INC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 209095 | GLENMARK PHARMS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 210208 | LUPIN LTD |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 075338 | MYLAN |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211207 | PAI HOLDINGS PHARM |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211401 | RISING |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074249 | TARO |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 209974 | TELIGENT |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211836 | TORRENT |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 210034 | XIROMED |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211074 | ZYDUS PHARMS |
| CORMAX | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074220 | AKORN |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English