Details for New Drug Application (NDA): 021067
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The generic ingredient in ASMANEX TWISTHALER is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
Summary for 021067
Tradename: | ASMANEX TWISTHALER |
Applicant: | Organon Llc |
Ingredient: | mometasone furoate |
Patents: | 0 |
Pharmacology for NDA: 021067
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 021067
Suppliers and Packaging for NDA: 021067
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067 | NDA | Organon LLC | 78206-114 | 78206-114-01 | 1 POUCH in 1 CARTON (78206-114-01) / 1 INHALER in 1 POUCH / 120 INHALANT in 1 INHALER |
ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067 | NDA | Organon LLC | 78206-114 | 78206-114-02 | 1 POUCH in 1 CARTON (78206-114-02) / 1 INHALER in 1 POUCH / 60 INHALANT in 1 INHALER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.22MG/INH | ||||
Approval Date: | Mar 30, 2005 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.11MG/INH | ||||
Approval Date: | Feb 1, 2008 | TE: | RLD: | Yes |
Expired US Patents for NDA 021067
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-002 | Feb 1, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-002 | Feb 1, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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