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Generated: March 19, 2019

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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 West-ward Pharms Int 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-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
Summary for 088252
Applicant:West-ward Pharms Int
Formulation / Manufacturing:see details
Pharmacology for NDA: 088252
Medical Subject Heading (MeSH) Categories for 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength1MG/ML
Approval Date:Sep 1, 1983TE:RLD:No

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