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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 two 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 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: 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 54288-103-10 10 AMPULE in 1 BOX (54288-103-10) > 1 mL in 1 AMPULE
EPINEPHRINE
epinephrine
SOLUTION;IV (INFUSION), INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 205029 NDA Belcher Pharmaceuticals, LLC 62250-103 62250-103-10 10 AMPULE in 1 BOX (62250-103-10) > 1 mL in 1 AMPULE

Summary 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:9,283,197Patent Expiration:Aug 15, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS
Patent:9,283,197Patent 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:9,283,197Patent Expiration:Aug 15, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:INDUCTION AND MAINTENANCE OF MYDRIASIS DURING INTRAOCULAR SURGERY


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