Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIBRAMYCIN | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 12/06/1967 | ORIG-1 | Approval | UNKNOWN |
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-92 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050006s092,050007s034,050480s058,050533s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050006Orig1s092; 050007Orig1s034; 050480Orig1s058; 050533Orig1s047ltr.pdf | |
| 12/03/2018 | SUPPL-91 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050006s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050006s091ltr.pdf | |
| 07/26/2017 | SUPPL-89 | 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-88 | 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-87 | 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-86 | 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-85 | 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-84 | 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-82 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf | |
| 02/06/2008 | SUPPL-79 | 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/2008/050006s079ltr.pdf | |
| 03/12/2004 | SUPPL-76 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf |
| 06/18/2002 | SUPPL-74 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf |
| 12/15/1992 | SUPPL-73 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/31/1982 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 10/19/1981 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1981 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1980 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1980 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/12/1980 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 09/19/1979 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/1979 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/19/1978 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/1978 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 07/12/1978 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 03/13/1978 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 09/20/1977 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 09/21/1977 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1977 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1976 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1976 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/1976 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1976 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1976 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1976 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 12/01/1975 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/1975 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/1975 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1975 | SUPPL-48 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/18/1975 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 09/24/1974 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1974 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/21/1974 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1974 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 04/16/1974 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 10/02/1973 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/1973 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/1973 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 10/30/1973 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 10/30/1973 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 10/30/1973 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 07/02/1973 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/16/1973 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 09/18/1972 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/23/1972 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 06/09/1972 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/16/1971 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1971 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/12/1971 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 02/22/1971 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1971 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/09/1970 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1970 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/01/1970 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/12/1970 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/1970 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/1969 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/07/1969 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1969 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1969 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1969 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/12/1969 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/1969 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/11/1969 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 12/30/1968 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/18/1968 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1968 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/19/1968 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/08/1968 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/11/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/05/1968 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/11/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/23/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/21/1983 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/29/1983 | SUPPL-1 | Labeling |
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-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050006s092,050007s034,050480s058,050533s047lbl.pdf | |
| 12/03/2018 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050006s091lbl.pdf | |
| 07/26/2017 | SUPPL-89 | 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-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf | |
| 03/31/2016 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf | |
| 09/12/2014 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf | |
| 09/04/2013 | SUPPL-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf | |
| 04/29/2013 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf | |
| 05/11/2011 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf | |
| 02/06/2008 | SUPPL-79 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf |
VIBRAMYCIN
FOR SUSPENSION;ORAL; EQ 25MG BASE/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065454 | CHARTWELL |
| DOXYCYCLINE | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 201678 | LUPIN LTD |
| VIBRAMYCIN | DOXYCYCLINE | EQ 25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050006 | PFIZER |