Details for New Drug Application (NDA): 021067
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NDA 021067 describes ASMANEX TWISTHALER, which is a drug marketed by Organon Llc and is included in one NDA. It is available from one supplier. Additional details are available on the ASMANEX TWISTHALER profile page.
The generic ingredient in ASMANEX TWISTHALER is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
The generic ingredient in ASMANEX TWISTHALER is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-six 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 | 6,949,532*PED | ⤷ Get Started Free |
| Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | 6,240,918*PED | ⤷ Get Started Free |
| Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | 8,173,172*PED | ⤷ Get Started Free |
| Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | 5,829,434*PED | ⤷ Get Started Free |
| Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-002 | Feb 1, 2008 | 6,057,307*PED | ⤷ Get Started Free |
| Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-002 | Feb 1, 2008 | 6,677,322*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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