Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075091
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 50MG;200MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;100MG TABLET, EXTENDED RELEASE;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
09/30/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-091_Carbidopa%20and%20Levodopa_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75091ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-091_Carbidopa.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/27/2015 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

05/14/2012 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

10/01/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/2002 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/07/2001 SUPPL-6 Labeling

Label is not available on this site.

08/11/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/2000 SUPPL-3 Labeling

Label is not available on this site.

04/21/2000 SUPPL-2 Labeling

Label is not available on this site.

04/21/2000 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/30/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-091_Carbidopa%20and%20Levodopa_prntlbl.pdf

CARBIDOPA AND LEVODOPA

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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