Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073589
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/28/1992 | 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 |
|---|---|---|---|---|---|
| 11/05/2015 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/05/2011 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2009 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/06/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/04/2002 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/04/2002 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CARBIDOPA AND LEVODOPA
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 | 216537 | AUROBINDO PHARMA LTD |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 073589 | DR REDDYS LABS SA |
| 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 | 216505 | RUBICON |
| 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 |