Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 211619

Expand all

DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: DOXEPIN HYDROCHLORIDE
Proprietary Name: DOXEPIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211619
Product Number: 001
Approval Date: Mar 9, 2021
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: DOXEPIN HYDROCHLORIDE
Proprietary Name: DOXEPIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211619
Product Number: 002
Approval Date: Mar 9, 2021
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: DOXEPIN HYDROCHLORIDE
Proprietary Name: DOXEPIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211619
Product Number: 003
Approval Date: Mar 9, 2021
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
EQ 75MG BASE
Marketing Status: Prescription

Active Ingredient: DOXEPIN HYDROCHLORIDE
Proprietary Name: DOXEPIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211619
Product Number: 004
Approval Date: Mar 9, 2021
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: DOXEPIN HYDROCHLORIDE
Proprietary Name: DOXEPIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211619
Product Number: 005
Approval Date: Mar 9, 2021
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information