Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062644
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLEOCIN | CLINDAMYCIN PALMITATE HYDROCHLORIDE | EQ 75MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | AA | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/07/1986 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/14/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/22/2019 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/22/2019 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2017 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 11/07/2016 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/07/2016 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/07/2016 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/21/2007 | SUPPL-15 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/062644s015lbl.pdf | |
| 12/11/2014 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/29/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/21/2007 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/062644s015lbl.pdf |
CLEOCIN
FOR SOLUTION;ORAL; EQ 75MG BASE/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN | CLINDAMYCIN PALMITATE HYDROCHLORIDE | EQ 75MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 062644 | PFIZER |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | CLINDAMYCIN PALMITATE HYDROCHLORIDE | EQ 75MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 203513 | AMNEAL PHARMS |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | CLINDAMYCIN PALMITATE HYDROCHLORIDE | EQ 75MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 202409 | AUROBINDO PHARMA LTD |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | CLINDAMYCIN PALMITATE HYDROCHLORIDE | EQ 75MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 206958 | CHARTWELL RX |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | CLINDAMYCIN PALMITATE HYDROCHLORIDE | EQ 75MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 207047 | HERITAGE PHARMS INC |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | CLINDAMYCIN PALMITATE HYDROCHLORIDE | EQ 75MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 201821 | LYNE |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | CLINDAMYCIN PALMITATE HYDROCHLORIDE | EQ 75MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 090902 | PADAGIS US |