Product Details for ANDA 060625
OMNIPEN (AMPICILLIN) (AMPICILLIN/AMPICILLIN TRIHYDRATE)
100MG/ML
Marketing Status: Discontinued
125MG/5ML
Marketing Status: Discontinued
250MG/5ML
Marketing Status: Discontinued
500MG/5ML
Marketing Status: Discontinued
100MG/ML
Marketing Status: Discontinued
Active Ingredient: AMPICILLIN/AMPICILLIN TRIHYDRATE
Proprietary Name: OMNIPEN (AMPICILLIN)
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 100MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A060625
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
OMNIPEN (AMPICILLIN) (AMPICILLIN/AMPICILLIN TRIHYDRATE)
Proprietary Name: OMNIPEN (AMPICILLIN)
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 100MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A060625
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
125MG/5ML
Marketing Status: Discontinued
Active Ingredient: AMPICILLIN/AMPICILLIN TRIHYDRATE
Proprietary Name: OMNIPEN (AMPICILLIN)
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A060625
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
OMNIPEN (AMPICILLIN) (AMPICILLIN/AMPICILLIN TRIHYDRATE)
Proprietary Name: OMNIPEN (AMPICILLIN)
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A060625
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
250MG/5ML
Marketing Status: Discontinued
Active Ingredient: AMPICILLIN/AMPICILLIN TRIHYDRATE
Proprietary Name: OMNIPEN (AMPICILLIN)
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A060625
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
OMNIPEN (AMPICILLIN) (AMPICILLIN/AMPICILLIN TRIHYDRATE)
Proprietary Name: OMNIPEN (AMPICILLIN)
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A060625
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
500MG/5ML
Marketing Status: Discontinued
Active Ingredient: AMPICILLIN/AMPICILLIN TRIHYDRATE
Proprietary Name: OMNIPEN (AMPICILLIN)
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 500MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A060625
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: OMNIPEN (AMPICILLIN)
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 500MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A060625
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH AYERST LABORATORIES
Marketing Status: Discontinued
Patent and Exclusivity Information