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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021171

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DEMEROL (MEPERIDINE HYDROCHLORIDE)
25MG/ML
Marketing Status: Prescription
Active Ingredient: MEPERIDINE HYDROCHLORIDE
Proprietary Name: DEMEROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 25MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021171
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DEMEROL (MEPERIDINE HYDROCHLORIDE)
50MG/ML
Marketing Status: Prescription
Active Ingredient: MEPERIDINE HYDROCHLORIDE
Proprietary Name: DEMEROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021171
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DEMEROL (MEPERIDINE HYDROCHLORIDE)
75MG/ML
Marketing Status: Prescription
Active Ingredient: MEPERIDINE HYDROCHLORIDE
Proprietary Name: DEMEROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 75MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021171
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DEMEROL (MEPERIDINE HYDROCHLORIDE)
100MG/ML
Marketing Status: Prescription
Active Ingredient: MEPERIDINE HYDROCHLORIDE
Proprietary Name: DEMEROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021171
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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