Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211158
Company: AMNEAL
Company: AMNEAL
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 |
---|---|---|---|---|---|---|---|
08/02/2018 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211158s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211158Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211158Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/12/2021 | SUPPL-6 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211158s006lbl.pdf | ||
11/10/2020 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211158s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211158Orig1s005ltr.pdf | |
07/31/2020 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211158s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211158Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/12/2021 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211158s006lbl.pdf | |
11/10/2020 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211158s005lbl.pdf | |
07/31/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211158s003lbl.pdf | |
08/02/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211158s000lbl.pdf |
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 |