Details for New Drug Application (NDA): 078128
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NDA 078128 describes ZIDOVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla Ltd, Am Regent, Liaoning Chengda, Aurobindo, Aurobindo Pharma, Cipla, Hec Pharm, Hetero Labs Ltd Iii, Hikma, Norvium Bioscience, and Ranbaxy Labs Ltd, and is included in fifteen NDAs. It is available from two suppliers. Additional details are available on the ZIDOVUDINE profile page.
The generic ingredient in ZIDOVUDINE is zidovudine. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the zidovudine profile page.
The generic ingredient in ZIDOVUDINE is zidovudine. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the zidovudine profile page.
Summary for 078128
| Tradename: | ZIDOVUDINE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | zidovudine |
| Patents: | 0 |
Pharmacology for NDA: 078128
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 078128
Suppliers and Packaging for NDA: 078128
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZIDOVUDINE | zidovudine | CAPSULE;ORAL | 078128 | ANDA | Aurobindo Pharma Limited | 65862-107 | 65862-107-01 | 100 CAPSULE in 1 BOTTLE (65862-107-01) |
| ZIDOVUDINE | zidovudine | CAPSULE;ORAL | 078128 | ANDA | Aurobindo Pharma Limited | 65862-107 | 65862-107-10 | 10 BLISTER PACK in 1 CARTON (65862-107-10) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 27, 2006 | TE: | AB | RLD: | No | ||||
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