Product Details for NDA 050261
DECLOMYCIN (DEMECLOCYCLINE HYDROCHLORIDE)
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DEMECLOCYCLINE HYDROCHLORIDE
Proprietary Name: DECLOMYCIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050261
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: COREPHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
DECLOMYCIN (DEMECLOCYCLINE HYDROCHLORIDE)
Proprietary Name: DECLOMYCIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050261
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: COREPHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DEMECLOCYCLINE HYDROCHLORIDE
Proprietary Name: DECLOMYCIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050261
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: COREPHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
DECLOMYCIN (DEMECLOCYCLINE HYDROCHLORIDE)
Proprietary Name: DECLOMYCIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050261
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: COREPHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DEMECLOCYCLINE HYDROCHLORIDE
Proprietary Name: DECLOMYCIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050261
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: COREPHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DECLOMYCIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050261
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: COREPHARMA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information