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
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE از شرکت NUVO PHARMS INC
Abbreviated New Drug Application (ANDA): 211421
Company: NUVO PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE | 5MG;2.5MG | CAPSULE;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 07/07/2020 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211421Orig1s000ltr.pdf |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
CAPSULE;ORAL; 5MG;2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE | 5MG;2.5MG | CAPSULE;ORAL | Prescription | No | AB | 214065 | ALKEM LABS LTD |
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE | 5MG;2.5MG | CAPSULE;ORAL | Prescription | No | AB | 214698 | DR REDDYS |
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE | 5MG;2.5MG | CAPSULE;ORAL | Prescription | No | AB | 213530 | ECI PHARMS LLC |
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE | 5MG;2.5MG | CAPSULE;ORAL | Prescription | No | AB | 210579 | MISEMER |
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE | 5MG;2.5MG | CAPSULE;ORAL | Prescription | No | AB | 211421 | NUVO PHARMS INC |
| LIBRAX | CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE | 5MG;2.5MG | CAPSULE;ORAL | Prescription | Yes | AB | 012750 | BAUSCH |
حتما بخوانید : CHLORDIAZEPOXIDE HYDROCHLORIDE از شرکت WATSON LABS
منبع : www.accessdata.fda.gov
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