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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205415
Company: NOSTRUM LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PINDOLOL PINDOLOL 5MG TABLET;ORAL Prescription AB No No
PINDOLOL PINDOLOL 10MG 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
01/13/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205415Orig1s000ltr.pdf

PINDOLOL

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
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

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
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
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