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Details for New Drug Application (NDA): 021443

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NDA 021443 describes ENJUVIA, which is a drug marketed by Teva Womens and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the ENJUVIA profile page.

The generic ingredient in ENJUVIA is estrogens, conjugated synthetic b. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the estrogens, conjugated synthetic b profile page.

Summary for NDA: 021443

Tradename:
ENJUVIA
Applicant:
Teva Womens
Ingredient:
estrogens, conjugated synthetic b
Patents:2
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021443

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENJUVIA
estrogens, conjugated synthetic b
TABLET;ORAL 021443 NDA Teva Women's Health, Inc. 51285-406 51285-406-02 100 TABLET, FILM COATED in 1 BOTTLE (51285-406-02)
ENJUVIA
estrogens, conjugated synthetic b
TABLET;ORAL 021443 NDA Teva Women's Health, Inc. 51285-407 51285-407-02 100 TABLET, FILM COATED in 1 BOTTLE (51285-407-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.3MG
Approval Date:Dec 20, 2004TE:RLD:No
Patent:6,660,726Patent Expiration:Mar 8, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
Patent:6,855,703Patent Expiration:Feb 12, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
Patent:6,660,726Patent Expiration:Mar 8, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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