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 BIONPHARMA INC
Abbreviated New Drug Application (ANDA): 081297
Company: BIONPHARMA 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 |
|---|---|---|---|---|---|---|---|
| 01/29/1993 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/20/2011 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/13/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/03/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1993 | SUPPL-1 | Manufacturing (CMC) |
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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