Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206661
Company: APOZEAL PHARMS
Company: APOZEAL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG/5ML;60MG/5ML | SOLUTION;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/23/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |