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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 073609


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NDA 073609 describes PINDOLOL, which is a drug marketed by Ani Pharms, Aurobindo Pharma Usa, Bayshore Pharms Llc, Cosette, 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 nine 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. Nine suppliers are listed for this compound. Additional details are available on the pindolol profile page.
Summary for 073609
Tradename:PINDOLOL
Applicant:Ani Pharms
Ingredient:pindolol
Patents:0
Pharmacology for NDA: 073609
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 073609
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PINDOLOL pindolol TABLET;ORAL 073609 ANDA Marlex Pharmaceuticals, Inc. 10135-743 10135-743-01 100 TABLET in 1 BOTTLE (10135-743-01)
PINDOLOL pindolol TABLET;ORAL 073609 ANDA Marlex Pharmaceuticals, Inc. 10135-744 10135-744-01 100 TABLET in 1 BOTTLE (10135-744-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 29, 1993TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 29, 1993TE:ABRLD:No

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