Details for New Drug Application (NDA): 021997
✉ Email this page to a colleague
NDA 021997 describes EDLUAR, which is a drug marketed by Mylan Speciality Lp 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: | Mylan Speciality Lp |
| Ingredient: | zolpidem tartrate |
| Patents: | 2 |
Pharmacology for NDA: 021997
| Mechanism of Action | GABA A Agonists |
| 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 | Meda Pharmaceuticals Inc. | 0037-6010 | 0037-6010-02 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (0037-6010-02) / 2 TABLET in 1 BLISTER PACK |
| EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997 | NDA | Meda Pharmaceuticals Inc. | 0037-6010 | 0037-6010-93 | 5 BLISTER PACK in 1 CARTON (0037-6010-93) / 6 TABLET in 1 BLISTER PACK (0037-6010-35) |
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: | ⤷ Subscribe | Patent Expiration: | Feb 25, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET | ||||||||
| Patent: | ⤷ Subscribe | 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: | ⤷ Subscribe | 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 |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-002 | Mar 13, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-002 | Mar 13, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
