Details for New Drug Application (NDA): 022036
✉ Email this page to a colleague
The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Forty-nine 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: | 15 |
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) |
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: | ⤷ Try a Trial | Patent Expiration: | May 18, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF INSOMNIA | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 11, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF INSOMNIA | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 20, 2027 | 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription