Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 091503

Expand all

BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
0.25%
Marketing Status: Prescription

Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: BUPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.25%
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A091503
Product Number: 001
Approval Date: Oct 18, 2011
Applicant Holder Full Name: STERISCIENCE PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
0.5%
Marketing Status: Prescription

Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: BUPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5%
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A091503
Product Number: 002
Approval Date: Oct 18, 2011
Applicant Holder Full Name: STERISCIENCE PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information