Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209556
Company: TELIGENT PHARMA INC
Company: TELIGENT PHARMA INC
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 11/21/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209556Orig1s000ltr.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 | TELIGENT PHARMA INC |
| LOCOID | HYDROCORTISONE BUTYRATE | 0.1% | LOTION;TOPICAL | Prescription | Yes | AB | 022076 | BAUSCH |
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