Product Details for NDA 021045
PLAN B (LEVONORGESTREL)
0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LEVONORGESTREL
Proprietary Name: PLAN B
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021045
Product Number: 001
Approval Date: Jul 28, 1999
Applicant Holder Full Name: FOUNDATION CONSUMER HEALTHCARE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
PLAN B (LEVONORGESTREL)
Proprietary Name: PLAN B
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021045
Product Number: 001
Approval Date: Jul 28, 1999
Applicant Holder Full Name: FOUNDATION CONSUMER HEALTHCARE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LEVONORGESTREL
Proprietary Name: PLAN B
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021045
Product Number: 002
Approval Date: Aug 24, 2006
Applicant Holder Full Name: FOUNDATION CONSUMER HEALTHCARE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PLAN B
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021045
Product Number: 002
Approval Date: Aug 24, 2006
Applicant Holder Full Name: FOUNDATION CONSUMER HEALTHCARE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information