Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019268

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CYTOTEC (MISOPROSTOL)
0.1MG
Marketing Status: Prescription

Active Ingredient: MISOPROSTOL
Proprietary Name: CYTOTEC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019268
Product Number: 003
Approval Date: Sep 21, 1990
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CYTOTEC (MISOPROSTOL)
0.2MG
Marketing Status: Prescription

Active Ingredient: MISOPROSTOL
Proprietary Name: CYTOTEC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019268
Product Number: 001
Approval Date: Dec 27, 1988
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information