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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019951

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NDA 019951 describes RETROVIR, which is a drug marketed by Viiv Hlthcare and is included in four NDAs. It is available from one supplier. Additional details are available on the RETROVIR profile page.

The generic ingredient in RETROVIR is zidovudine. There are twenty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the zidovudine profile page.

Summary for 019951

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 019951

Medical Subject Heading (MeSH) Categories for 019951

Suppliers and Packaging for NDA: 019951

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RETROVIR zidovudine INJECTABLE;INJECTION 019951 NDA ViiV Healthcare Company 49702-213 49702-213-26 5 VIAL, SINGLE-USE in 1 CARTON (49702-213-26) > 20 mL in 1 VIAL, SINGLE-USE (49702-213-01)
RETROVIR zidovudine INJECTABLE;INJECTION 019951 NDA ViiV Healthcare Company 49702-213 49702-213-05 10 VIAL, SINGLE-USE in 1 TRAY (49702-213-05) > 20 mL in 1 VIAL, SINGLE-USE (49702-213-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Feb 2, 1990TE:APRLD:Yes

Expired Orange Book Patents for NDA: 019951

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv HlthcareRETROVIRzidovudineINJECTABLE;INJECTION019951-001Feb 2, 1990► Subscribe► Subscribe
Viiv HlthcareRETROVIRzidovudineINJECTABLE;INJECTION019951-001Feb 2, 1990► Subscribe► Subscribe
Viiv HlthcareRETROVIRzidovudineINJECTABLE;INJECTION019951-001Feb 2, 1990► Subscribe► Subscribe
Viiv HlthcareRETROVIRzidovudineINJECTABLE;INJECTION019951-001Feb 2, 1990► Subscribe► Subscribe
Viiv HlthcareRETROVIRzidovudineINJECTABLE;INJECTION019951-001Feb 2, 1990► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Fish and Richardson
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Daiichi Sankyo

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