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Details for New Drug Application (NDA): 012541

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NDA 012541 describes DEPO-PROVERA, which is a drug marketed by Pharmacia And Upjohn and is included in two NDAs. It is available from seven suppliers. Additional details are available on the DEPO-PROVERA profile page.

The generic ingredient in DEPO-PROVERA is medroxyprogesterone acetate. There are nineteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the medroxyprogesterone acetate profile page.

Summary for NDA: 012541

Pharmacology for NDA: 012541

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 012541

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEPO-PROVERA
medroxyprogesterone acetate
INJECTABLE;INJECTION 012541 NDA Pharmacia and Upjohn Company LLC 0009-0626 0009-0626-01 1 VIAL in 1 CARTON (0009-0626-01) > 2.5 mL in 1 VIAL
DEPO-PROVERA
medroxyprogesterone acetate
INJECTABLE;INJECTION 012541 NDA Physicians Total Care, Inc. 54868-3348 54868-3348-1 1 VIAL in 1 BOX (54868-3348-1) > 2.5 mL in 1 VIAL

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired Orange Book Patents for NDA: 012541

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
DEPO-PROVERA
medroxyprogesterone acetate
INJECTABLE;INJECTION012541-002Approved Prior to Jan 1, 19824,038,389► subscribe
Pharmacia And Upjohn
DEPO-PROVERA
medroxyprogesterone acetate
INJECTABLE;INJECTION012541-003Approved Prior to Jan 1, 19824,038,389► 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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