Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071345
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOXIDIL MINOXIDIL 10MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/03/1987 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
05/19/2020 SUPPL-38 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

03/24/2003 SUPPL-18 Labeling

Label is not available on this site.

04/25/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/17/1996 SUPPL-12 Labeling

Label is not available on this site.

05/13/1993 SUPPL-11 Labeling

Label is not available on this site.

01/28/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/07/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/07/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/01/1988 SUPPL-5 Labeling

Label is not available on this site.

03/01/1988 SUPPL-4 Labeling

Label is not available on this site.

08/12/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/12/1987 SUPPL-2 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

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