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Details for New Drug Application (NDA): 020472

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NDA 020472 describes ESTRING, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from three suppliers. Additional details are available on the ESTRING profile page.

The generic ingredient in ESTRING is estradiol. There are seventy-five drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the estradiol profile page.

Summary for NDA: 020472

Tradename:
ESTRING
Applicant:
Pharmacia And Upjohn
Ingredient:
estradiol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020472

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 020472

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRING
estradiol
INSERT, EXTENDED RELEASE;VAGINAL 020472 NDA Pharmacia and Upjohn Company LLC 0013-2150 0013-2150-36 1 POUCH in 1 CARTON (0013-2150-36) > 1 RING in 1 POUCH
ESTRING
estradiol
INSERT, EXTENDED RELEASE;VAGINAL 020472 NDA Physicians Total Care, Inc. 54868-5538 54868-5538-0 1 RING in 1 POUCH (54868-5538-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INSERT, EXTENDED RELEASE;VAGINALStrength0.0075MG/24HR
Approval Date:Apr 26, 1996TE:RLD:Yes

Expired Orange Book Patents for NDA: 020472

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
ESTRING
estradiol
INSERT, EXTENDED RELEASE;VAGINAL020472-001Apr 26, 19964,871,543► subscribe
Pharmacia And Upjohn
ESTRING
estradiol
INSERT, EXTENDED RELEASE;VAGINAL020472-001Apr 26, 19965,188,835► subscribe
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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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