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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 021583

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NDA 021583 describes DEPO-SUBQ PROVERA 104, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the DEPO-SUBQ PROVERA 104 profile page.

The generic ingredient in DEPO-SUBQ PROVERA 104 is medroxyprogesterone acetate. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the medroxyprogesterone acetate profile page.
Summary for 021583
Applicant:Pharmacia And Upjohn
Ingredient:medroxyprogesterone acetate
Formulation / Manufacturing:see details
Pharmacology for NDA: 021583
Suppliers and Packaging for NDA: 021583
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEPO-SUBQ PROVERA 104 medroxyprogesterone acetate INJECTABLE;SUBCUTANEOUS 021583 NDA Pharmacia and Upjohn Company LLC 0009-4709 0009-4709-13 1 SYRINGE in 1 CARTON (0009-4709-13) > .65 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength104MG/0.65ML
Approval Date:Dec 17, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 15, 2020Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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