Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210209
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | LOTION;TOPICAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/17/2018 | ORIG-1 | Approval | UNKNOWN |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210209Orig1s000TAltr.pdf |
HYDROCORTISONE BUTYRATE
LOTION;TOPICAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | LOTION;TOPICAL | Prescription | No | AB | 210209 | LUPIN LTD |
HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | LOTION;TOPICAL | Prescription | No | AB | 209556 | THE J MOLNER |