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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 210163


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NDA 210163 describes PERPHENAZINE, which is a drug marketed by Pharm Assoc, Ani Pharms, Appco, Endo Operations, Macleods Pharms Ltd, Mylan, Rising, Sandoz, Watson Labs Inc, Wilshire Pharms Inc, Zydus Pharms, Chartwell Rx, Fosun Pharma, Ivax Sub Teva Pharms, Par Pharm, Sun Pharm Industries, and Watson Labs, and is included in forty-nine NDAs. It is available from sixteen suppliers. Additional details are available on the PERPHENAZINE profile page.

The generic ingredient in PERPHENAZINE is amitriptyline hydrochloride; perphenazine. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amitriptyline hydrochloride; perphenazine profile page.
Summary for 210163
Tradename:PERPHENAZINE
Applicant:Appco
Ingredient:perphenazine
Patents:0
Pharmacology for NDA: 210163
Medical Subject Heading (MeSH) Categories for 210163
Suppliers and Packaging for NDA: 210163
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PERPHENAZINE perphenazine TABLET;ORAL 210163 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-799 23155-799-01 100 TABLET in 1 BOTTLE (23155-799-01)
PERPHENAZINE perphenazine TABLET;ORAL 210163 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-800 23155-800-01 100 TABLET in 1 BOTTLE (23155-800-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:May 18, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:May 18, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:May 18, 2022TE:ABRLD:No

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