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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. There is one tentative approval for this compound. Additional details are available on the zidovudine profile page.

Summary for NDA: 019951

Viiv Hlthcare
Therapeutic Class:Antivirals

Pharmacology for NDA: 019951

Suppliers and Packaging for NDA: 019951

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
INJECTABLE;INJECTION019951-001Feb 2, 19904,837,208<disabled>
Viiv Hlthcare
INJECTABLE;INJECTION019951-001Feb 2, 19904,724,232<disabled>
Viiv Hlthcare
INJECTABLE;INJECTION019951-001Feb 2, 19904,828,838<disabled>
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