Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206697
Company: AMNEAL
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXENATIDE SYNTHETIC | EXENATIDE SYNTHETIC | 300MCG/1.2ML (250MCG/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| EXENATIDE SYNTHETIC | EXENATIDE SYNTHETIC | 600MCG/2.4ML (250MCG/ML) | INJECTABLE;SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 11/19/2024 | 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 |
|---|---|---|---|---|---|
| 10/02/2026 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/02/2026 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/02/2026 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |