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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205029

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NDA 205029 describes EPINEPHRINE, which is a drug marketed by Armstrong Pharms and Belcher Pharms Llc and is included in two NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the EPINEPHRINE profile page.

The generic ingredient in EPINEPHRINE is epinephrine. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 205029
Tradename:EPINEPHRINE
Applicant:Belcher Pharms Llc
Ingredient:epinephrine
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205029
Suppliers and Packaging for NDA: 205029
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPINEPHRINE epinephrine SOLUTION;IV (INFUSION), INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 205029 NDA BPI Labs, LLC 54288-103 N 54288-103-10
EPINEPHRINE epinephrine SOLUTION;IV (INFUSION), INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 205029 NDA Belcher Pharmaceuticals, LLC 62250-103 N 62250-103-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION), INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:Jul 29, 2014TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Aug 15, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS
Patent:➤ Sign UpPatent Expiration:Aug 15, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
Patent:➤ Sign UpPatent Expiration:Aug 15, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:INDUCTION AND MAINTENANCE OF MYDRIASIS DURING INTRAOCULAR SURGERY

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