Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050533
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIBRA-TABS | DOXYCYCLINE HYCLATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/15/1980 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2019 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050006s092,050007s034,050480s058,050533s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050006Orig1s092;%20050007Orig1s034;%20050480Orig1s058;%20050533Orig1s047ltr.p | |
| 12/03/2018 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050533s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050533s046ltr.pdf | |
| 07/26/2017 | SUPPL-45 | 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/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045ltr.pdf |
| 12/21/2016 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s088,050007Orig1s031,050442Orig1s019,050480Orig1s055,050533Orig1s044ltr.pdf | |
| 03/31/2016 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf | |
| 09/12/2014 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf | |
| 09/04/2013 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s085,050007Orig1s026,050480Orig1s051,050533Orig1s041ltr.pdf | |
| 04/29/2013 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s084,050007Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf | |
| 05/11/2011 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf | |
| 02/06/2008 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050533s036ltr.pdf | |
| 03/12/2004 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf |
| 05/15/2002 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/2002 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf |
| 03/06/2000 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/08/1998 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/15/1992 | SUPPL-27 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/11/1992 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 05/22/1984 | SUPPL-25 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/13/1984 | SUPPL-24 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/17/1984 | SUPPL-23 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/21/1983 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/01/1983 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/31/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/02/1982 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/16/1982 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/25/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/17/1981 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/15/1981 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1981 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/24/1991 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/23/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/05/1981 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1981 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/21/1980 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/12/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/25/1980 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1981 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/21/1980 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/20/2019 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050006s092,050007s034,050480s058,050533s047lbl.pdf | |
| 12/03/2018 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050533s046lbl.pdf | |
| 07/26/2017 | SUPPL-45 | 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/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045lbl.pdf |
| 12/21/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf | |
| 03/31/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf | |
| 09/12/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf | |
| 09/04/2013 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf | |
| 04/29/2013 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf | |
| 05/11/2011 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf | |
| 02/06/2008 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf |