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
BENZONATATE از شرکت APOTEX INC
Abbreviated New Drug Application (ANDA): 091310
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription |
AA |
No | No |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/16/2015 | ORIG-1 | Approval |
|
Label is not available on this site. |
BENZONATATE
CAPSULE;ORAL; 100MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 040682 | ALEMBIC LABS |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 091310 | APOTEX INC |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 211518 | ASCENT PHARMS INC |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 081297 | BIONPHARMA INC |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 202765 | CSPC-NBP PHARM |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 040851 | MIKART |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 206948 | PURACAP PHARM LLC |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 210562 | QINGDAO BAHEAL PHARM |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 091133 | STRIDES PHARMA |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 040627 | THEPHARMANETWORK LLC |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 040597 | ZYDUS PHARMS USA |
| TESSALON | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | Yes | AA | 011210 | PFIZER |
CAPSULE;ORAL; 200MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 040682 | ALEMBIC LABS |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 091310 | APOTEX INC |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 211518 | ASCENT PHARMS INC |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 081297 | BIONPHARMA INC |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 202765 | CSPC-NBP PHARM |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 040851 | MIKART |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 206948 | PURACAP PHARM LLC |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 210562 | QINGDAO BAHEAL PHARM |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 091133 | STRIDES PHARMA |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 040749 | THEPHARMANETWORK LLC |
| BENZONATATE | BENZONATATE | 200MG | CAPSULE;ORAL | Prescription | No | AA | 040597 | ZYDUS PHARMS USA |
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