اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CLINDAMYCIN PALMITATE HYDROCHLORIDE از شرکت HERITAGE PHARMS INC
Abbreviated New Drug Application (ANDA): 207047
Company: HERITAGE PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 05/11/2018 | ORIG-1 | Approval |
STANDARD |
|
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 | 206958 | ALEMBIC LABS |
| 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 | 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 |
منبع : www.accessdata.fda.gov
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