Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040247
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCORTISONE | HYDROCORTISONE | 2.5% | LOTION;TOPICAL | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 07/23/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40247ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
HYDROCORTISONE
LOTION;TOPICAL; 2.5%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE | HYDROCORTISONE | 2.5% | LOTION;TOPICAL | Prescription | No | AT | 040247 | TARO |
| STIE-CORT | HYDROCORTISONE | 2.5% | LOTION;TOPICAL | Prescription | No | AT | 089074 | PADAGIS US |