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Details for New Drug Application (NDA): 070791

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NDA 070791 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds, Par Pharm, Purepac Pharm, Teva Pharms, Wockhardt, Silarx, Pharm Assoc, Sandoz, Watson Labs, Quantum Pharmics, Mylan Pharms Inc, Actavis Elizabeth, Dava Pharms Inc, and New River, and is included in fifty-five NDAs. It is available from twenty-four suppliers. Additional details are available on the DOXEPIN HYDROCHLORIDE profile page.

The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for NDA: 070791

Tradename:
DOXEPIN HYDROCHLORIDE
Applicant:
Mylan Pharms Inc
Ingredient:
doxepin hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 070791

Suppliers and Packaging for NDA: 070791

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL 070791 ANDA Mylan Pharmaceuticals Inc. 0378-1049 0378-1049-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-01)
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL 070791 ANDA Mylan Pharmaceuticals Inc. 0378-1049 0378-1049-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:May 13, 1986TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:May 13, 1986TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:May 13, 1986TE:ABRLD:Yes


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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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