Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204439
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIGECYCLINE | TIGECYCLINE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
12/21/2018 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/01/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
TIGECYCLINE
POWDER;INTRAVENOUS; 50MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TIGECYCLINE | TIGECYCLINE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211158 | AMNEAL |
TIGECYCLINE | TIGECYCLINE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 204439 | APOTEX |
TIGECYCLINE | TIGECYCLINE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206335 | EUGIA PHARMA |
TIGECYCLINE | TIGECYCLINE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 205645 | FRESENIUS KABI USA |
TIGECYCLINE | TIGECYCLINE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 214020 | MEITHEAL |
TIGECYCLINE | TIGECYCLINE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 091620 | SANDOZ |
TYGACIL | TIGECYCLINE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 021821 | PF PRISM CV |