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Details for New Drug Application (NDA): 018642

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NDA 018642 describes BETA-VAL, which is a drug marketed by G And W Labs Inc and is included in three NDAs. It is available from one supplier. Additional details are available on the BETA-VAL profile page.

The generic ingredient in BETA-VAL is betamethasone valerate. There are sixty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the betamethasone valerate profile page.

Summary for NDA: 018642

Tradename:
BETA-VAL
Applicant:
G And W Labs Inc
Ingredient:
betamethasone valerate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 018642

Suppliers and Packaging for NDA: 018642

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETA-VAL
betamethasone valerate
CREAM;TOPICAL 018642 ANDA G&W Laboratories, Inc. 0713-0326 0713-0326-15 15 g in 1 TUBE (0713-0326-15)
BETA-VAL
betamethasone valerate
CREAM;TOPICAL 018642 ANDA G&W Laboratories, Inc. 0713-0326 0713-0326-37 45 g in 1 TUBE (0713-0326-37)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 0.1% BASE
Approval Date:Mar 24, 1983TE:ABRLD:No


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