Details for New Drug Application (NDA): 022036
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The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Forty 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: | See Plans and Pricing | Patent Expiration: | May 18, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF INSOMNIA | ||||||||
Patent: | See Plans and Pricing | Patent Expiration: | Apr 11, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF INSOMNIA | ||||||||
Patent: | See Plans and Pricing | 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 | See Plans and Pricing | See Plans and Pricing |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | See Plans and Pricing | See Plans and Pricing |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | See Plans and Pricing | See Plans and Pricing |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | See Plans and Pricing | See Plans and Pricing |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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