Details for New Drug Application (NDA): 075841
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NDA 075841 describes PAMIDRONATE DISODIUM, which is a drug marketed by Aesgen, Am Regent, Areva Pharms, Dr Reddys, Fresenius Kabi Usa, Hikma, Hospira, Mn Pharms, Mylan Labs Ltd, Sagent Pharms Inc, Sun Pharma Global, and Teva Pharms Usa, and is included in fourteen NDAs. It is available from two suppliers. Additional details are available on the PAMIDRONATE DISODIUM profile page.
The generic ingredient in PAMIDRONATE DISODIUM is pamidronate disodium. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pamidronate disodium profile page.
The generic ingredient in PAMIDRONATE DISODIUM is pamidronate disodium. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pamidronate disodium profile page.
Summary for 075841
| Tradename: | PAMIDRONATE DISODIUM |
| Applicant: | Hospira |
| Ingredient: | pamidronate disodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075841
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAMIDRONATE DISODIUM | pamidronate disodium | INJECTABLE;INJECTION | 075841 | ANDA | Hospira, Inc. | 61703-324 | 61703-324-18 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-324-18) / 10 mL in 1 VIAL, SINGLE-DOSE |
| PAMIDRONATE DISODIUM | pamidronate disodium | INJECTABLE;INJECTION | 075841 | ANDA | Hospira, Inc. | 61703-325 | 61703-325-18 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-325-18) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/10ML (3MG/ML) | ||||
| Approval Date: | Jun 27, 2002 | TE: | AP2 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 60MG/10ML (6MG/ML) | ||||
| Approval Date: | Jun 27, 2002 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 90MG/10ML (9MG/ML) | ||||
| Approval Date: | Jun 27, 2002 | TE: | AP2 | RLD: | No | ||||
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