Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021821
Company: PF PRISM CV
Company: PF PRISM CV
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYGACIL | TIGECYCLINE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/15/2005 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021821lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021821ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-821_Tygacil.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/23/2020 | SUPPL-49 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021821s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021821Orig1s049ltr.pdf | |
| 01/16/2020 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021821s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021821Orig1s048ltr.pdf | |
| 04/16/2018 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021821s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021821Orig1s045ltr.pdf | |
| 01/19/2016 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s043ltr.pdf | |
| 06/29/2016 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s042ltr.pdf |
| 05/31/2016 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s039ltr.pdf | |
| 05/23/2013 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s037ltr.pdf | |
| 01/09/2014 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/2013 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s026,s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021821Orig1s031.pdf | |
| 07/16/2010 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf | |
| 09/26/2013 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s026,s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021821Orig1s026.pdf | |
| 07/16/2010 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf | |
| 06/26/2009 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s022ltr.pdf |
| 07/16/2010 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf | |
| 01/29/2009 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf | |
| 03/20/2009 | SUPPL-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf | |
| 03/20/2009 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf | |
| 02/10/2009 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s016ltr.pdf | |
| 01/29/2009 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf | |
| 03/20/2009 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf | |
| 01/29/2009 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf |
| 05/18/2007 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s010ltr.pdf | |
| 04/03/2007 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s007ltr.pdf | |
| 01/24/2007 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s006ltr.pdf |
| 07/12/2006 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021821s003, 021821s004_ltr.pdf |
| 07/12/2006 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021821s003, 021821s004_ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/23/2020 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021821s049lbl.pdf | |
| 06/23/2020 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021821s049lbl.pdf | |
| 01/16/2020 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021821s048lbl.pdf | |
| 04/16/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021821s045lbl.pdf | |
| 06/29/2016 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s042lbl.pdf |
| 05/31/2016 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s039lbl.pdf | |
| 01/19/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s043lbl.pdf | |
| 09/26/2013 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf | |
| 09/26/2013 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf | |
| 05/23/2013 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s037lbl.pdf | |
| 07/16/2010 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s027lbl.pdf | |
| 07/16/2010 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s025lbl.pdf | |
| 07/16/2010 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s021lbl.pdf | |
| 03/20/2009 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf | |
| 03/20/2009 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf | |
| 03/20/2009 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf | |
| 02/10/2009 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s016lbl.pdf | |
| 01/29/2009 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf | |
| 01/29/2009 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf | |
| 05/18/2007 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s010lbl.pdf | |
| 04/03/2007 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s007lbl.pdf | |
| 06/15/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021821lbl.pdf |
TYGACIL
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 |