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Details for New Drug Application (NDA): 022036
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NDA 022036 describes SILENOR, which is a drug marketed by Currax and is included in one NDA. It is available from three suppliers. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SILENOR profile page.
The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 022036
| Tradename: | SILENOR |
| Applicant: | Currax |
| Ingredient: | doxepin hydrochloride |
| Patents: | 11 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 022036
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-4810 | 0378-4810-93 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-4810-93) |
| SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-4811 | 0378-4811-93 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-4811-93) |
Paragraph IV (Patent) Challenges for 022036
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SILENOR | TABLET;ORAL | doxepin hydrochloride | 022036 | 2010-09-16 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 3MG BASE | ||||
| Approval Date: | Mar 17, 2010 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | May 18, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF INSOMNIA | ||||||||
| Patent: | Start Trial | Patent Expiration: | Apr 11, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF INSOMNIA | ||||||||
| Patent: | Start Trial | Patent Expiration: | Feb 17, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF INSOMNIA | ||||||||
Expired US Patents for NDA 022036
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | Start Trial | Start Trial |
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | Start Trial | Start Trial |
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | Start Trial | Start Trial |
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | Start Trial | Start Trial |
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | Start Trial | Start Trial |
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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