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Generated: January 19, 2019

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Details for New Drug Application (NDA): 088138

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NDA 088138 describes HYDROCORTISONE IN ABSORBASE, which is a drug marketed by Cmp Pharma Inc and is included in one NDA. It is available from one supplier. Additional details are available on the HYDROCORTISONE IN ABSORBASE profile page.

The generic ingredient in HYDROCORTISONE IN ABSORBASE is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 088138
Applicant:Cmp Pharma Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 088138
Medical Subject Heading (MeSH) Categories for 088138
Suppliers and Packaging for NDA: 088138
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE IN ABSORBASE hydrocortisone OINTMENT;TOPICAL 088138 ANDA Solubiomix 69499-322 69499-322-10 110 g in 1 JAR (69499-322-10)
HYDROCORTISONE IN ABSORBASE hydrocortisone OINTMENT;TOPICAL 088138 ANDA Solubiomix 69499-343 69499-343-25 25 g in 1 JAR (69499-343-25)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength1%
Approval Date:Sep 6, 1985TE:ATRLD:No

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