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
CARBIDOPA AND LEVODOPA از شرکت ACTAVIS ELIZABETH
Abbreviated New Drug Application (ANDA): 074260
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/03/1993 | 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 |
|---|---|---|---|---|---|
| 02/04/2021 | SUPPL-55 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/15/2016 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/04/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/2009 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 06/19/2007 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 03/20/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/20/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/15/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CARBIDOPA AND LEVODOPA
TABLET;ORAL; 10MG;100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 074260 | ACTAVIS ELIZABETH |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 077120 | APOTEX INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 073618 | MAYNE PHARMA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 090324 | MYLAN |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 214092 | SCIEGEN PHARMS INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 078536 | SUN PHARM INDS |
| SINEMET | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 017555 | ORGANON |
TABLET;ORAL; 25MG;100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 074260 | ACTAVIS ELIZABETH |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 077120 | APOTEX INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 073589 | MAYNE PHARMA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 090324 | MYLAN |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 214092 | SCIEGEN PHARMS INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 078536 | SUN PHARM INDS |
| SINEMET | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 017555 | ORGANON |
TABLET;ORAL; 25MG;250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 074260 | ACTAVIS ELIZABETH |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 077120 | APOTEX INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 073607 | MAYNE PHARMA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 090324 | MYLAN |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 214092 | SCIEGEN PHARMS INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 078536 | SUN PHARM INDS |
| SINEMET | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | Yes | AB | 017555 | ORGANON |
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