Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072709
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOXIDIL MINOXIDIL 10MG TABLET;ORAL Prescription AB No No
MINOXIDIL MINOXIDIL 2.5MG 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
12/13/1995 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
05/15/2018 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

06/16/2004 SUPPL-11 Labeling

Label is not available on this site.

06/06/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/28/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

MINOXIDIL

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINOXIDIL MINOXIDIL 10MG TABLET;ORAL Prescription No AB 071839 PAR PHARM
MINOXIDIL MINOXIDIL 10MG TABLET;ORAL Prescription No AB 072709 SUN PHARM INDUSTRIES
MINOXIDIL MINOXIDIL 10MG TABLET;ORAL Prescription No AB 071345 WATSON LABS

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINOXIDIL MINOXIDIL 2.5MG TABLET;ORAL Prescription No AB 071826 PAR PHARM
MINOXIDIL MINOXIDIL 2.5MG TABLET;ORAL Prescription No AB 072709 SUN PHARM INDUSTRIES
MINOXIDIL MINOXIDIL 2.5MG TABLET;ORAL Prescription No AB 071344 WATSON LABS

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