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Details for New Drug Application (NDA): 088252

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NDA 088252 describes DEXAMETHASONE INTENSOL, which is a drug marketed by Roxane and is included in one NDA. It is available from two suppliers. Additional details are available on the DEXAMETHASONE INTENSOL profile page.

The generic ingredient in DEXAMETHASONE INTENSOL is dexamethasone. There are thirty-eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

Summary for NDA: 088252

Pharmacology for NDA: 088252

Suppliers and Packaging for NDA: 088252

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE INTENSOL
dexamethasone
CONCENTRATE;ORAL 088252 ANDA West-Ward Pharmaceuticals Corp. 0054-3176 0054-3176-44 30 mL in 1 BOTTLE, GLASS (0054-3176-44)
DEXAMETHASONE INTENSOL
dexamethasone
CONCENTRATE;ORAL 088252 ANDA Carilion Materials Management 68151-5026 68151-5026-4 1 mL in 1 PACKAGE (68151-5026-4)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength1MG/ML
Approval Date:Sep 1, 1983TE:RLD:Yes


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