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
CHLORZOXAZONE از شرکت MIKART
Abbreviated New Drug Application (ANDA): 040861
Company: MIKART
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORZOXAZONE | CHLORZOXAZONE | 375MG | TABLET;ORAL | Prescription |
AB |
No | Yes |
| CHLORZOXAZONE | CHLORZOXAZONE | 750MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 06/01/2010 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/040861s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/13/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CHLORZOXAZONE
TABLET;ORAL; 375MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORZOXAZONE | CHLORZOXAZONE | 375MG | TABLET;ORAL | Prescription | No | AB | 212185 | GLENMARK PHARMS LTD |
| CHLORZOXAZONE | CHLORZOXAZONE | 375MG | TABLET;ORAL | Prescription | No | AB | 212053 | I3 PHARMS |
| CHLORZOXAZONE | CHLORZOXAZONE | 375MG | TABLET;ORAL | Prescription | No | AB | 211849 | MAYNE PHARMA |
| CHLORZOXAZONE | CHLORZOXAZONE | 375MG | TABLET;ORAL | Prescription | No | AB | 040861 | MIKART |
| CHLORZOXAZONE | CHLORZOXAZONE | 375MG | TABLET;ORAL | Prescription | No | AB | 212253 | NOVITIUM PHARMA |
| CHLORZOXAZONE | CHLORZOXAZONE | 375MG | TABLET;ORAL | Prescription | No | AB | 212743 | PAR PHARM INC |
| CHLORZOXAZONE | CHLORZOXAZONE | 375MG | TABLET;ORAL | Prescription | No | AB | 212898 | TEVA PHARMS USA INC |
TABLET;ORAL; 750MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORZOXAZONE | CHLORZOXAZONE | 750MG | TABLET;ORAL | Prescription | No | AB | 212185 | GLENMARK PHARMS LTD |
| CHLORZOXAZONE | CHLORZOXAZONE | 750MG | TABLET;ORAL | Prescription | No | AB | 212053 | I3 PHARMS |
| CHLORZOXAZONE | CHLORZOXAZONE | 750MG | TABLET;ORAL | Prescription | No | AB | 211849 | MAYNE PHARMA |
| CHLORZOXAZONE | CHLORZOXAZONE | 750MG | TABLET;ORAL | Prescription | No | AB | 040861 | MIKART |
| CHLORZOXAZONE | CHLORZOXAZONE | 750MG | TABLET;ORAL | Prescription | No | AB | 212253 | NOVITIUM PHARMA |
| CHLORZOXAZONE | CHLORZOXAZONE | 750MG | TABLET;ORAL | Prescription | No | AB | 212743 | PAR PHARM INC |
| CHLORZOXAZONE | CHLORZOXAZONE | 750MG | TABLET;ORAL | Prescription | No | AB | 212898 | TEVA PHARMS USA INC |
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