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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216943

CLINDAMYCIN PHOSPHATE AND TRETINOIN (CLINDAMYCIN PHOSPHATE; TRETINOIN)
1.2%;0.025%
Marketing Status: Prescription
Active Ingredient: CLINDAMYCIN PHOSPHATE; TRETINOIN
Proprietary Name: CLINDAMYCIN PHOSPHATE AND TRETINOIN
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 1.2%;0.025%
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A216943
Product Number: 001
Approval Date: Sep 1, 2023
Applicant Holder Full Name: ENCUBE ETHICALS PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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