Details for New Drug Application (NDA): 021997
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NDA 021997 describes EDLUAR, which is a drug marketed by Viatris and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EDLUAR profile page.
The generic ingredient in EDLUAR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
The generic ingredient in EDLUAR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 021997
| Tradename: | EDLUAR |
| Applicant: | Viatris |
| Ingredient: | zolpidem tartrate |
| Patents: | 2 |
Pharmacology for NDA: 021997
| Mechanism of Action | GABA A Receptor Positive Modulators |
| Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 021997
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997 | NDA | Viatris Specialty LLC | 0037-6010 | 0037-6010-93 | 5 BLISTER PACK in 1 CARTON (0037-6010-93) / 6 TABLET in 1 BLISTER PACK (0037-6010-35) |
| EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997 | NDA | Viatris Specialty LLC | 0037-6050 | 0037-6050-93 | 5 BLISTER PACK in 1 CARTON (0037-6050-93) / 6 TABLET in 1 BLISTER PACK (0037-6050-35) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 5MG | ||||
| Approval Date: | Mar 13, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 25, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 6, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 10MG | ||||
| Approval Date: | Mar 13, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 25, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET | ||||||||
Expired US Patents for NDA 021997
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| Viatris | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-002 | Mar 13, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| Viatris | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-002 | Mar 13, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| Viatris | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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