Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201821
Company: LYNE
Company: LYNE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PALMITATE HYDROCHLORIDE | CLINDAMYCIN PALMITATE HYDROCHLORIDE | EQ 75MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | AA | No | 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 |
---|---|---|---|---|---|---|---|
08/28/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/22/2022 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
08/22/2022 | SUPPL-3 | Labeling |
Label is not available on this site. |
CLINDAMYCIN PALMITATE HYDROCHLORIDE
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 |