Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076963

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PILOCARPINE HYDROCHLORIDE (PILOCARPINE HYDROCHLORIDE)
5MG
Marketing Status: Prescription

Active Ingredient: PILOCARPINE HYDROCHLORIDE
Proprietary Name: PILOCARPINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076963
Product Number: 001
Approval Date: Dec 22, 2004
Applicant Holder Full Name: AMICI PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

PILOCARPINE HYDROCHLORIDE (PILOCARPINE HYDROCHLORIDE)
7.5MG
Marketing Status: Prescription

Active Ingredient: PILOCARPINE HYDROCHLORIDE
Proprietary Name: PILOCARPINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076963
Product Number: 002
Approval Date: Feb 27, 2007
Applicant Holder Full Name: AMICI PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information