New Drug Application (NDA): 050639
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Showing 1 to 3 of 3 entries
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes |
---|---|---|---|---|---|---|
08/30/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Showing 1 to 1 of 1 entries
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note |
---|---|---|---|---|
05/20/2022 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
12/04/2021 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
03/04/2020 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
06/19/2019 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
04/16/2018 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
05/02/2017 | SUPPL-37 | 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. |
05/02/2017 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
08/05/2016 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
08/05/2016 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
05/20/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
|
03/24/2016 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
09/18/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
|
06/25/2014 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
06/25/2014 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
06/25/2014 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
10/09/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
|
06/26/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
|
06/07/2011 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
04/14/2008 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
|
02/21/2008 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
|
09/29/2004 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
|
01/28/2004 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
03/09/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
|
12/12/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
|
07/17/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
|
03/17/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
|
12/20/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
|
02/21/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
|
04/05/1993 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
|
05/21/1992 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
|
06/11/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
|
04/18/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
|
04/10/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
Showing 1 to 33 of 33 entries
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note |
---|---|---|---|---|
05/20/2022 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | |
12/04/2021 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | |
03/04/2020 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | |
06/19/2019 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | |
04/16/2018 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | |
05/02/2017 | SUPPL-37 | 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. |
05/02/2017 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | |
08/05/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | |
08/05/2016 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | |
03/24/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | |
06/25/2014 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | |
06/25/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | |
06/25/2014 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | |
04/14/2008 | SUPPL-16 | Labeling | Label (PDF) | |
02/21/2008 | SUPPL-15 | Labeling | Label (PDF) | |
09/29/2004 | SUPPL-13 | Labeling | Label (PDF) |
Showing 1 to 16 of 16 entries