Details for New Drug Application (NDA): 204587
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NDA 204587 describes RITONAVIR, which is a drug marketed by Hikma, Quagen, Amneal, Aurobindo Pharma Ltd, Cipla, and Hetero Labs Ltd Iii, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the RITONAVIR profile page.
The generic ingredient in RITONAVIR is ritonavir. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the ritonavir profile page.
The generic ingredient in RITONAVIR is ritonavir. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the ritonavir profile page.
Summary for 204587
| Tradename: | RITONAVIR |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | ritonavir |
| Patents: | 0 |
Pharmacology for NDA: 204587
Medical Subject Heading (MeSH) Categories for 204587
Suppliers and Packaging for NDA: 204587
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RITONAVIR | ritonavir | TABLET;ORAL | 204587 | ANDA | Camber Pharmaceuticals, Inc. | 31722-597 | 31722-597-12 | 120 TABLET in 1 BOTTLE (31722-597-12) |
| RITONAVIR | ritonavir | TABLET;ORAL | 204587 | ANDA | Camber Pharmaceuticals, Inc. | 31722-597 | 31722-597-30 | 30 TABLET in 1 BOTTLE (31722-597-30) |
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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