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 MYLAN
Abbreviated New Drug Application (ANDA): 075091
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1999 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-091_Carbidopa%20and%20Levodopa_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/27/2015 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/14/2012 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/01/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/2002 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/07/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/11/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/11/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/04/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/21/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/21/2000 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/30/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-091_Carbidopa%20and%20Levodopa_prntlbl.pdf |
CARBIDOPA AND LEVODOPA
TABLET, EXTENDED RELEASE;ORAL; 50MG;200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202323 | ACCORD HLTHCARE |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210341 | ALEMBIC PHARMS LTD |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076212 | APOTEX |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076521 | IMPAX LABS |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075091 | MYLAN |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214091 | SCIEGEN PHARMS INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077828 | SUN PHARM INDS |
TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202323 | ACCORD HLTHCARE |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210341 | ALEMBIC PHARMS LTD |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076212 | APOTEX |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076521 | IMPAX LABS |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075091 | MYLAN |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214091 | SCIEGEN PHARMS INC |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077828 | SUN PHARM INDS |
نظرات کاربران