Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017830
Company: ATON
Company: ATON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LODOSYN | CARBIDOPA | 25MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/25/1977 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/21/2014 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf | |
| 09/05/2002 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/2002 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/2001 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2014 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf | |
| 02/21/2014 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf | |
| 02/21/2014 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf | |
| 02/21/2014 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf | |
| 01/06/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2014 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017830Orig1s014,016,017,018,019,030ltr.pdf | |
| 01/08/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/27/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/30/1985 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/08/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1983 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/27/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/14/1981 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/21/1980 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/28/1980 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/28/1977 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/21/2014 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf | |
| 02/21/2014 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf | |
| 02/21/2014 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf | |
| 02/21/2014 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf | |
| 02/21/2014 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf | |
| 02/21/2014 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017830s014s016s017s018s019s030lbl.pdf |
LODOSYN
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA | CARBIDOPA | 25MG | TABLET;ORAL | Prescription | No | AB | 211055 | AUROBINDO PHARMA |
| CARBIDOPA | CARBIDOPA | 25MG | TABLET;ORAL | Prescription | No | AB | 205304 | EDENBRIDGE PHARMS |
| CARBIDOPA | CARBIDOPA | 25MG | TABLET;ORAL | Prescription | No | AB | 204763 | NOVEL LABS INC |
| CARBIDOPA | CARBIDOPA | 25MG | TABLET;ORAL | Prescription | No | AB | 217961 | REGCON HOLDINGS |
| CARBIDOPA | CARBIDOPA | 25MG | TABLET;ORAL | Prescription | No | AB | 209910 | ZYDUS PHARMS |
| LODOSYN | CARBIDOPA | 25MG | TABLET;ORAL | Prescription | Yes | AB | 017830 | ATON |