Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021919
Company: AMYLIN
Company: AMYLIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BYETTA | EXENATIDE SYNTHETIC | 300UGM/1.2ML (250UGM/ML) | INJECTABLE; SUBCUTANEOUS | Prescription | None | No | No |
| BYETTA | EXENATIDE SYNTHETIC | 600UGM/2.4ML (250UGM/ML) | INJECTABLE; SUBCUTANEOUS | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 10/30/2009 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021919_byetta_toc.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/30/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf |