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
ACETAZOLAMIDE از شرکت NOVAST LABS
Abbreviated New Drug Application (ANDA): 203434
Company: NOVAST LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 09/30/2016 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203434Orig1s000ltr.pdf |
ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207659 | ACCORD HLTHCARE |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210423 | ALEMBIC PHARMS LTD |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205301 | CADILA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 040904 | HERITAGE PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090779 | INDICUS PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207401 | MICRO LABS LTD INDIA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204691 | NOSTRUM LABS INC |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203434 | NOVAST LABS |
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