Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212296
Company: WILSHIRE PHARMS INC
Company: WILSHIRE PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEOXYCHOLIC ACID | DEOXYCHOLIC ACID | 20MG/2ML (10MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 04/02/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212296Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/29/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DEOXYCHOLIC ACID
SOLUTION;SUBCUTANEOUS; 20MG/2ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEOXYCHOLIC ACID | DEOXYCHOLIC ACID | 20MG/2ML (10MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 212296 | WILSHIRE PHARMS INC |
| KYBELLA | DEOXYCHOLIC ACID | 20MG/2ML (10MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | Yes | AP | 206333 | ABBVIE |