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Details for New Drug Application (NDA): 020800

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NDA 020800 describes TWINJECT 0.3, which is a drug marketed by Amedra Pharms and is included in one NDA. It is available from eight suppliers. There are two patents protecting this drug. Additional details are available on the TWINJECT 0.3 profile page.

The generic ingredient in TWINJECT 0.3 is epinephrine. There are seventeen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

Summary for NDA: 020800

Tradename:
ADRENACLICK
Applicant:
Amedra Pharms
Ingredient:
epinephrine
Patents:2
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020800

Suppliers and Packaging for NDA: 020800

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800 NDA AUTHORIZED GENERIC Rebel Distributors Corp 21695-947 21695-947-01 1 CARTRIDGE in 1 CASE (21695-947-01) > 1 INJECTION in 1 CARTRIDGE
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800 NDA Amedra Pharmaceuticals LLC 52054-803 52054-803-02 2 CASE in 1 CARTON (52054-803-02) > 1 SYRINGE, GLASS in 1 CASE > .15 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 0.3MG/DELIVERY
Approval Date:May 30, 2003TE:RLD:No
Patent:7,297,136Patent Expiration:Jan 18, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:7,621,891Patent Expiration:Feb 4, 2025Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 0.15MG/DELIVERY
Approval Date:May 28, 2004TE:RLD:No
Patent:7,297,136Patent Expiration:Jan 18, 2025Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020800

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amedra Pharms
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-003Nov 25, 20095,665,071► subscribe
Amedra Pharms
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-004Nov 25, 20095,665,071► 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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