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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075091
Company: MYLAN

Products on ANDA 075091

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075091

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.

Labels for ANDA 075091

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

Therapeutic Equivalents for ANDA 075091

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	210341	ALEMBIC
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	214091	SCIEGEN PHARMS INC
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077828	SUN PHARM INDS

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	210341	ALEMBIC
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	214091	SCIEGEN PHARMS INC
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077828	SUN PHARM INDS

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