Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017830
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 204291 ALVOGEN
CARBIDOPA CARBIDOPA 25MG TABLET;ORAL Prescription No AB 203261 ANI PHARMS INC
CARBIDOPA CARBIDOPA 25MG TABLET;ORAL Prescription No AB 211055 AUROBINDO PHARMA LTD
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 209910 ZYDUS PHARMS
LODOSYN CARBIDOPA 25MG TABLET;ORAL Prescription Yes AB 017830 ATON

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