Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019856
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SINEMET CR CARBIDOPA; LEVODOPA 50MG;200MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
SINEMET CR CARBIDOPA; LEVODOPA 25MG;100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes 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
05/30/1991 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/17/2014 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf
02/01/2011 SUPPL-27 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019856s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017555s070,019856s027ltr.pdf
12/31/2008 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019856s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019856s025ltr.pdf
07/17/2014 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf
09/05/2002 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/11/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/16/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/17/2014 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf
05/02/2000 SUPPL-15 Labeling

Label is not available on this site.

06/06/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/10/1999 SUPPL-12 Labeling

Label is not available on this site.

08/04/1999 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/10/1999 SUPPL-9 Labeling

Label is not available on this site.

05/10/1999 SUPPL-7 Labeling

Label is not available on this site.

05/10/1999 SUPPL-6 Labeling

Label is not available on this site.

05/07/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/16/1996 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/07/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/24/1992 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/10/1999 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
07/17/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf
07/17/2014 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf
07/17/2014 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf
02/01/2011 SUPPL-27 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019856s027lbl.pdf
12/31/2008 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019856s025lbl.pdf

SINEMET CR

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 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 077828 SUN PHARM INDS
SINEMET CR CARBIDOPA; LEVODOPA 50MG;200MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019856 MERCK SHARP DOHME

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 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 077828 SUN PHARM INDS
SINEMET CR CARBIDOPA; LEVODOPA 25MG;100MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019856 MERCK SHARP DOHME

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