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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208804

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ALBUTEROL SULFATE (ALBUTEROL SULFATE)
EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: ALBUTEROL SULFATE
Proprietary Name: ALBUTEROL SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208804
Product Number: 001
Approval Date: May 21, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
ALBUTEROL SULFATE (ALBUTEROL SULFATE)
EQ 4MG BASE
Marketing Status: Prescription
Active Ingredient: ALBUTEROL SULFATE
Proprietary Name: ALBUTEROL SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208804
Product Number: 002
Approval Date: May 21, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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