Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214193

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PILOCARPINE HYDROCHLORIDE (PILOCARPINE HYDROCHLORIDE)
1%
Marketing Status: Prescription

Active Ingredient: PILOCARPINE HYDROCHLORIDE
Proprietary Name: PILOCARPINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; OPHTHALMIC
Strength: 1%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A214193
Product Number: 001
Approval Date: Sep 21, 2020
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PILOCARPINE HYDROCHLORIDE (PILOCARPINE HYDROCHLORIDE)
2%
Marketing Status: Prescription

Active Ingredient: PILOCARPINE HYDROCHLORIDE
Proprietary Name: PILOCARPINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; OPHTHALMIC
Strength: 2%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A214193
Product Number: 002
Approval Date: Sep 21, 2020
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PILOCARPINE HYDROCHLORIDE (PILOCARPINE HYDROCHLORIDE)
4%
Marketing Status: Prescription

Active Ingredient: PILOCARPINE HYDROCHLORIDE
Proprietary Name: PILOCARPINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; OPHTHALMIC
Strength: 4%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A214193
Product Number: 003
Approval Date: Sep 21, 2020
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information