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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-eight 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

Pharmacia And Upjohn
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
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
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
INSERT, EXTENDED RELEASE;VAGINAL020472-001Apr 26, 19964,871,543► subscribe
Pharmacia And Upjohn
INSERT, EXTENDED RELEASE;VAGINAL020472-001Apr 26, 19965,188,835► subscribe
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