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Details for New Drug Application (NDA): 018013

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NDA 018013 describes PAMELOR, which is a drug marketed by Mallinckrodt Inc and Mallinckrodt Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the PAMELOR profile page.

The generic ingredient in PAMELOR is nortriptyline hydrochloride. There are ten drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.

Summary for NDA: 018013

Tradename:
PAMELOR
Applicant:
Mallinckrodt Llc
Ingredient:
nortriptyline hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 018013

Suppliers and Packaging for NDA: 018013

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAMELOR
nortriptyline hydrochloride
CAPSULE;ORAL 018013 NDA Mallinckrodt, Inc. 0406-9910 0406-9910-03 30 CAPSULE in 1 BOTTLE (0406-9910-03)
PAMELOR
nortriptyline hydrochloride
CAPSULE;ORAL 018013 NDA Mallinckrodt, Inc. 0406-9911 0406-9911-03 30 CAPSULE in 1 BOTTLE (0406-9911-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018013

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Llc
PAMELOR
nortriptyline hydrochloride
CAPSULE;ORAL018013-001Approved Prior to Jan 1, 19823,922,305► subscribe
Mallinckrodt Llc
PAMELOR
nortriptyline hydrochloride
CAPSULE;ORAL018013-003Approved Prior to Jan 1, 19823,922,305► subscribe
Mallinckrodt Llc
PAMELOR
nortriptyline hydrochloride
CAPSULE;ORAL018013-004Approved Prior to Jan 1, 19823,922,305► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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