Details for New Drug Application (NDA): 078541
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The generic ingredient in MOMETASONE FUROATE is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
Summary for 078541
Tradename: | MOMETASONE FUROATE |
Applicant: | Glenmark Generics |
Ingredient: | mometasone furoate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078541
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 078541
Suppliers and Packaging for NDA: 078541
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MOMETASONE FUROATE | mometasone furoate | CREAM;TOPICAL | 078541 | ANDA | NORTHSTAR RX LLC | 16714-974 | 16714-974-01 | 15 g in 1 TUBE (16714-974-01) |
MOMETASONE FUROATE | mometasone furoate | CREAM;TOPICAL | 078541 | ANDA | NORTHSTAR RX LLC | 16714-974 | 16714-974-02 | 45 g in 1 TUBE (16714-974-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
Approval Date: | May 28, 2008 | TE: | AB | RLD: | No |
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