Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017555
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SINEMET CARBIDOPA; LEVODOPA 10MG;100MG TABLET;ORAL Prescription AB Yes No
SINEMET CARBIDOPA; LEVODOPA 25MG;250MG TABLET;ORAL Prescription AB Yes Yes
SINEMET CARBIDOPA; LEVODOPA 25MG;100MG TABLET;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
05/02/1975 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination 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
07/17/2014 SUPPL-71 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf
02/01/2011 SUPPL-70 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017555s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017555s070,019856s027ltr.pdf
12/31/2008 SUPPL-69 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017555s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017555s069ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/017555Orig1s069.pdf
07/17/2014 SUPPL-68 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf
09/05/2002 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

10/11/2001 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

03/16/2001 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/2001 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/2001 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/2001 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

07/17/2014 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf
04/11/2001 SUPPL-55 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf
06/06/2000 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

04/04/2000 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

04/11/2001 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf
04/11/2001 SUPPL-50 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf
11/26/1997 SUPPL-48 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/04/1997 SUPPL-47 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/07/1997 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/11/2001 SUPPL-45 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf
05/16/1996 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/13/1995 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2001 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf
04/11/2001 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf
04/11/2001 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf
04/11/2001 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf
04/11/2001 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf
04/21/1988 SUPPL-35 Labeling

Label is not available on this site.

02/26/1988 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1986 SUPPL-33 Labeling

Label is not available on this site.

01/17/1986 SUPPL-32 Labeling

Label is not available on this site.

07/12/1985 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1985 SUPPL-30 Labeling

Label is not available on this site.

05/06/1985 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/02/1984 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/11/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1984 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1986 SUPPL-25 Labeling

Label is not available on this site.

01/17/1986 SUPPL-24 Labeling

Label is not available on this site.

01/17/1986 SUPPL-23 Labeling

Label is not available on this site.

05/04/1983 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1981 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/09/1983 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/02/1981 SUPPL-18 Labeling

Label is not available on this site.

09/09/1980 SUPPL-16 Labeling

Label is not available on this site.

01/12/1981 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/11/1980 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/29/1980 SUPPL-12 Labeling

Label is not available on this site.

01/29/1980 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/12/1980 SUPPL-10 Labeling

Label is not available on this site.

10/22/1979 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/13/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1980 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/24/1978 SUPPL-6 Labeling

Label is not available on this site.

04/29/1977 SUPPL-5 Labeling

Label is not available on this site.

01/25/1978 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/26/1978 SUPPL-3 Manufacturing (CMC)-Formulation

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-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf
07/17/2014 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf
07/17/2014 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf
02/01/2011 SUPPL-70 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017555s070lbl.pdf
12/31/2008 SUPPL-69 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017555s069lbl.pdf

SINEMET

TABLET;ORAL; 10MG;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 10MG;100MG TABLET;ORAL Prescription No AB 074260 ACTAVIS ELIZABETH
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 10MG;100MG TABLET;ORAL Prescription No AB 077120 APOTEX INC
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 10MG;100MG TABLET;ORAL Prescription No AB 073618 MAYNE PHARMA
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 10MG;100MG TABLET;ORAL Prescription No AB 090324 MYLAN
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 10MG;100MG TABLET;ORAL Prescription No AB 078536 SUN PHARM INDS
SINEMET CARBIDOPA; LEVODOPA 10MG;100MG TABLET;ORAL Prescription Yes AB 017555 MERCK SHARP DOHME

TABLET;ORAL; 25MG;250MG
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;250MG TABLET;ORAL Prescription No AB 074260 ACTAVIS ELIZABETH
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;250MG TABLET;ORAL Prescription No AB 077120 APOTEX INC
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;250MG TABLET;ORAL Prescription No AB 073607 MAYNE PHARMA
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;250MG TABLET;ORAL Prescription No AB 090324 MYLAN
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;250MG TABLET;ORAL Prescription No AB 078536 SUN PHARM INDS
SINEMET CARBIDOPA; LEVODOPA 25MG;250MG TABLET;ORAL Prescription Yes AB 017555 MERCK SHARP DOHME

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 073589 MAYNE PHARMA
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 078536 SUN PHARM INDS
SINEMET CARBIDOPA; LEVODOPA 25MG;100MG TABLET;ORAL Prescription Yes AB 017555 MERCK SHARP DOHME

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