Details for New Drug Application (NDA): 206614
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NDA 206614 describes RITONAVIR, which is a drug marketed by Hikma, Norvium Bioscience, Amneal, Aurobindo Pharma Ltd, Cipla, and Hetero Labs Ltd Iii, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the RITONAVIR profile page.
The generic ingredient in RITONAVIR is ritonavir. There are twenty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ritonavir profile page.
The generic ingredient in RITONAVIR is ritonavir. There are twenty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ritonavir profile page.
Summary for 206614
| Tradename: | RITONAVIR |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | ritonavir |
| Patents: | 0 |
Pharmacology for NDA: 206614
Medical Subject Heading (MeSH) Categories for 206614
Suppliers and Packaging for NDA: 206614
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RITONAVIR | ritonavir | TABLET;ORAL | 206614 | ANDA | American Health Packaging | 60687-420 | 60687-420-25 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-420-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-420-95) |
| RITONAVIR | ritonavir | TABLET;ORAL | 206614 | ANDA | Aurobindo Pharma Limited | 65862-687 | 65862-687-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-687-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 17, 2018 | TE: | AB | RLD: | No | ||||
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