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FDA Approval

ATROPEN Auto-Injector

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Meridian Medical Technologies LLC
DUNS: 049504624
Effective Date
September 15, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atropine(2 mg in 0.7 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Meridian Medical Technologies LLC

Meridian Medical Technologies LLC

049504624

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ATROPEN Auto-Injector

Product Details

NDC Product Code
11704-106
Application Number
NDA017106
Marketing Category
NDA (C73594)
Route of Administration
INTRAMUSCULAR
Effective Date
March 22, 2017
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT
AtropineActive
Code: 7C0697DR9IClass: ACTIBQuantity: 2 mg in 0.7 mL
glycerinInactive
Code: PDC6A3C0OXClass: IACT
phenolInactive
Code: 339NCG44TVClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT

ATROPEN Auto-Injector

Product Details

NDC Product Code
11704-104
Application Number
NDA017106
Marketing Category
NDA (C73594)
Route of Administration
INTRAMUSCULAR
Effective Date
March 22, 2017
AtropineActive
Code: 7C0697DR9IClass: ACTIBQuantity: 0.5 mg in 0.7 mL
phenolInactive
Code: 339NCG44TVClass: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT

ATROPEN Auto-Injector

Product Details

NDC Product Code
11704-107
Application Number
NDA017106
Marketing Category
NDA (C73594)
Route of Administration
INTRAMUSCULAR
Effective Date
March 22, 2017
AtropineActive
Code: 7C0697DR9IClass: ACTIBQuantity: 0.25 mg in 0.3 mL
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT

ATROPEN Auto-Injector

Product Details

NDC Product Code
11704-101
Application Number
NDA017106
Marketing Category
NDA (C73594)
Route of Administration
INTRAMUSCULAR
Effective Date
March 22, 2017
AtropineActive
Code: 7C0697DR9IClass: ACTIBQuantity: 2 mg in 0.7 mL
glycerinInactive
Code: PDC6A3C0OXClass: IACT
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
phenolInactive
Code: 339NCG44TVClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT

ATROPEN Auto-Injector

Product Details

NDC Product Code
11704-105
Application Number
NDA017106
Marketing Category
NDA (C73594)
Route of Administration
INTRAMUSCULAR
Effective Date
March 22, 2017
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
AtropineActive
Code: 7C0697DR9IClass: ACTIBQuantity: 1 mg in 0.7 mL
phenolInactive
Code: 339NCG44TVClass: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT
NitrogenInactive
Code: N762921K75Class: IACT
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