Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016949

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LIMBITROL (AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE)
EQ 12.5MG BASE;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Proprietary Name: LIMBITROL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG BASE;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N016949
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

LIMBITROL DS (AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE)
EQ 25MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Proprietary Name: LIMBITROL DS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N016949
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information