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Details for New Drug Application (NDA): 019555

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NDA 019555 describes DIPROLENE AF, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. Additional details are available on the DIPROLENE AF profile page.

The generic ingredient in DIPROLENE AF is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

Summary for NDA: 019555

Pharmacology for NDA: 019555

Suppliers and Packaging for NDA: 019555

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
betamethasone dipropionate
CREAM, AUGMENTED;TOPICAL 019555 NDA Merck Sharp & Dohme Corp. 0085-0517 0085-0517-01 1 TUBE in 1 BOX (0085-0517-01) > 15 g in 1 TUBE
betamethasone dipropionate
CREAM, AUGMENTED;TOPICAL 019555 NDA Merck Sharp & Dohme Corp. 0085-0517 0085-0517-04 1 TUBE in 1 BOX (0085-0517-04) > 50 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM, AUGMENTED;TOPICALStrengthEQ 0.05% BASE
Approval Date:Apr 27, 1987TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019555

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
betamethasone dipropionate
CREAM, AUGMENTED;TOPICAL019555-001Apr 27, 19874,489,071► subscribe
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