Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073609
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PINDOLOL PINDOLOL 10MG TABLET;ORAL Prescription AB No No
PINDOLOL PINDOLOL 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
03/29/1993 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
04/19/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/30/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/27/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/28/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/28/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/26/1993 SUPPL-3 Labeling

Label is not available on this site.

06/28/1993 SUPPL-2 Labeling

Label is not available on this site.

10/06/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PINDOLOL

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PINDOLOL PINDOLOL 10MG TABLET;ORAL Prescription No AB 073609 ANI PHARMS INC
PINDOLOL PINDOLOL 10MG TABLET;ORAL Prescription No AB 211712 BAYSHORE PHARMS LLC
PINDOLOL PINDOLOL 10MG TABLET;ORAL Prescription No AB 074019 MYLAN PHARMS INC
PINDOLOL PINDOLOL 10MG TABLET;ORAL Prescription No AB 205415 NOSTRUM LABS INC
PINDOLOL PINDOLOL 10MG TABLET;ORAL Prescription No AB 074063 SUN PHARM INDUSTRIES

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PINDOLOL PINDOLOL 5MG TABLET;ORAL Prescription No AB 073609 ANI PHARMS INC
PINDOLOL PINDOLOL 5MG TABLET;ORAL Prescription No AB 211712 BAYSHORE PHARMS LLC
PINDOLOL PINDOLOL 5MG TABLET;ORAL Prescription No AB 074019 MYLAN PHARMS INC
PINDOLOL PINDOLOL 5MG TABLET;ORAL Prescription No AB 205415 NOSTRUM LABS INC
PINDOLOL PINDOLOL 5MG TABLET;ORAL Prescription No AB 074063 SUN PHARM INDUSTRIES

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