Tigecycline ANDA 217477 Tentative Approval Hainan Poly Pharm
Summary
The FDA granted tentative approval to ANDA 217477 for Tigecycline 50MG/1VIAL Injection submitted by Hainan Poly Pharm. Co., Ltd. The action was recorded on April 23, 2026. Tentative approval means the application meets required FDA standards but cannot receive final approval due to patent or exclusivity issues. Marketing status is listed as None pending resolution.
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GovPing monitors FDA Drugs@FDA - New Applications and Actions for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 9 changes logged to date.
What changed
The FDA Drugs@FDA database records a tentative approval action for Hainan Poly Pharm Co., Ltd.'s Abbreviated New Drug Application for Tigecycline injection. The drug product contains 50MG TIGECYCLINE per vial in injection form. The approval is currently tentative with no final marketing status.
Affected parties including generic drug manufacturers and pharmaceutical companies should note that tentative approval does not authorize commercial marketing. The applicant cannot launch the product until final approval is granted, typically after relevant patents or exclusivity periods expire.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Abbreviated New Drug Application (ANDA): 217477
Company: HAINAN POLY PHARM. CO., LTD.
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| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIGECYCLINE | TIGECYCLINE | 50MG/1VIAL | INJECTION | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 04/23/2026 | ORIG-1 | Tentative Approval | STANDARD | Label is not available on this site. |
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