Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205479
Company: LGM PHARMA
Company: LGM PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ASPIRIN | ASPIRIN; HYDROCODONE BITARTRATE | 500MG;5MG | TABLET;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/28/2021 | 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 |
|---|---|---|---|---|---|
| 11/22/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/03/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2024 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2024 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |