Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086831
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription AB No Yes
CHLORTHALIDONE CHLORTHALIDONE 25MG 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
02/26/1981 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
08/22/2002 SUPPL-31 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/10/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/20/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/21/1993 SUPPL-26 Labeling

Label is not available on this site.

01/13/1992 SUPPL-24 Labeling

Label is not available on this site.

09/20/1991 SUPPL-23 Labeling

Label is not available on this site.

01/31/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/19/1989 SUPPL-21 Labeling

Label is not available on this site.

03/29/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/19/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/15/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/24/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/24/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CHLORTHALIDONE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription No AB 207204 AMNEAL PHARMS CO
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription No AB 210742 ARISE
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription No AB 211063 ATHEM
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription No AB 086831 MYLAN
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription No AB 206904 RICONPHARMA LLC
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription No AB 089286 SUN PHARM INDUSTRIES
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription No AB 207222 UMEDICA LABS PVT LTD
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription No AB 211627 UNICHEM LABS LTD
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription No AB 207813 ZYDUS PHARMS

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET;ORAL Prescription No AB 207204 AMNEAL PHARMS CO
CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET;ORAL Prescription No AB 210742 ARISE
CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET;ORAL Prescription No AB 211063 ATHEM
CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET;ORAL Prescription No AB 086831 MYLAN
CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET;ORAL Prescription No AB 206904 RICONPHARMA LLC
CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET;ORAL Prescription No AB 089286 SUN PHARM INDUSTRIES
CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET;ORAL Prescription No AB 207222 UMEDICA LABS PVT LTD
CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET;ORAL Prescription No AB 211627 UNICHEM LABS LTD
CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET;ORAL Prescription No AB 207813 ZYDUS PHARMS

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