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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040728

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BETHANECHOL CHLORIDE (BETHANECHOL CHLORIDE)
5MG
Marketing Status: Prescription
Active Ingredient: BETHANECHOL CHLORIDE
Proprietary Name: BETHANECHOL CHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A040728
Product Number: 002
Approval Date: Oct 26, 2007
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
BETHANECHOL CHLORIDE (BETHANECHOL CHLORIDE)
10MG
Marketing Status: Prescription
Active Ingredient: BETHANECHOL CHLORIDE
Proprietary Name: BETHANECHOL CHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A040728
Product Number: 003
Approval Date: Oct 26, 2007
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
BETHANECHOL CHLORIDE (BETHANECHOL CHLORIDE)
25MG
Marketing Status: Prescription
Active Ingredient: BETHANECHOL CHLORIDE
Proprietary Name: BETHANECHOL CHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A040728
Product Number: 004
Approval Date: Oct 26, 2007
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
BETHANECHOL CHLORIDE (BETHANECHOL CHLORIDE)
50MG
Marketing Status: Prescription
Active Ingredient: BETHANECHOL CHLORIDE
Proprietary Name: BETHANECHOL CHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A040728
Product Number: 001
Approval Date: Oct 26, 2007
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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