Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089286
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription AB No No
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
07/21/1986 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
11/08/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/08/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/15/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/29/1996 SUPPL-6 Labeling

Label is not available on this site.

06/22/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/01/1991 SUPPL-3 Labeling

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 210742 APPCO PHARMA LLC
CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET;ORAL Prescription No AB 211063 INVATECH PHARMA
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 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 210742 APPCO PHARMA LLC
CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET;ORAL Prescription No AB 211063 INVATECH PHARMA
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 207813 ZYDUS PHARMS

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