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Details for New Drug Application (NDA): 020701

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NDA 020701 describes CRINONE, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the CRINONE profile page.

The generic ingredient in CRINONE is progesterone. There are fifty-one drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the progesterone profile page.

Summary for NDA: 020701

Tradename:
CRINONE
Applicant:
Allergan Sales Llc
Ingredient:
progesterone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020701

Ingredient-typeProgesterone

Suppliers and Packaging for NDA: 020701

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CRINONE
progesterone
GEL;VAGINAL 020701 NDA Actavis Pharma, Inc. 52544-255 52544-255-24 6 APPLICATOR in 1 CARTON (52544-255-24) > 1.125 g in 1 APPLICATOR
CRINONE
progesterone
GEL;VAGINAL 020701 NDA Actavis Pharma, Inc. 52544-256 52544-256-02 2 APPLICATOR in 1 CARTON (52544-256-02) > 1.125 g in 1 APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;VAGINALStrength4%
Approval Date:Jul 31, 1997TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;VAGINALStrength8%
Approval Date:Jul 31, 1997TE:RLD:Yes

Expired Orange Book Patents for NDA: 020701

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
CRINONE
progesterone
GEL;VAGINAL020701-001Jul 31, 19974,615,697► subscribe
Allergan Sales Llc
CRINONE
progesterone
GEL;VAGINAL020701-002Jul 31, 19975,543,150► subscribe
Allergan Sales Llc
CRINONE
progesterone
GEL;VAGINAL020701-002Jul 31, 19974,615,697► subscribe
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