Details for New Drug Application (NDA): 022517
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The generic ingredient in NOCDURNA is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
Summary for 022517
Tradename: | NOCDURNA |
Applicant: | Ferring Pharms Inc |
Ingredient: | desmopressin acetate |
Patents: | 5 |
Suppliers and Packaging for NDA: 022517
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517 | NDA | Antares Pharma, Inc. | 54436-325 | 54436-325-30 | 3 BLISTER PACK in 1 CARTON (54436-325-30) / 10 TABLET in 1 BLISTER PACK (54436-325-10) |
NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517 | NDA | Antares Pharma, Inc. | 54436-350 | 54436-350-30 | 3 BLISTER PACK in 1 CARTON (54436-350-30) / 10 TABLET in 1 BLISTER PACK (54436-350-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | 0.0277MG | ||||
Approval Date: | Jun 21, 2018 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 21, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 21, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 2, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS |
Expired US Patents for NDA 022517
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-001 | Jun 21, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-001 | Jun 21, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-002 | Jun 21, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-002 | Jun 21, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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