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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073618
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 10MG;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-27 Labeling-Package Insert

Label is not available on this site.

07/05/2011 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

02/03/2011 SUPPL-24 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/30/2009 SUPPL-22 Labeling

Label is not available on this site.

11/06/2001 SUPPL-15 Labeling

Label is not available on this site.

01/04/2002 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

01/04/2002 SUPPL-13 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.

12/02/1999 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

02/12/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/28/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/10/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CARBIDOPA AND LEVODOPA

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 216537 AUROBINDO PHARMA LTD
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 216505 RUBICON
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 10MG;100MG TABLET;ORAL Prescription No AB 214092 SCIEGEN PHARMS INC
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 ORGANON
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