Details for New Drug Application (NDA): 021997
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The generic ingredient in EDLUAR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-five 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: | ⤷ Sign Up | Patent Expiration: | Feb 25, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET | ||||||||
Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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 | 021997-001 | Mar 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-002 | Mar 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-002 | Mar 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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