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Last Updated: May 25, 2020

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Details for New Drug Application (NDA): 209866

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NDA 209866 describes PINDOLOL, which is a drug marketed by Acp Nimble, Ani Pharms Inc, Bayshore Pharms Llc, Mylan Pharms Inc, Nostrum Labs, Nostrum Labs Inc, Purepac Pharm, Sun Pharm Industries, Watson Labs, and Zydus Pharms, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the PINDOLOL profile page.

The generic ingredient in PINDOLOL is pindolol. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the pindolol profile page.
Summary for 209866
Applicant:Zydus Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 209866
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 209866
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PINDOLOL pindolol TABLET;ORAL 209866 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1063 70710-1063-1 100 TABLET in 1 BOTTLE (70710-1063-1)
PINDOLOL pindolol TABLET;ORAL 209866 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1064 70710-1064-1 100 TABLET in 1 BOTTLE (70710-1064-1)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Aug 18, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Aug 18, 2017TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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