Details for New Drug Application (NDA): 209463
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NDA 209463 describes PANTOPRAZOLE SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Annora Pharma, Dexcel, Sun Pharm, Aspiro, Be Pharms, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hangzhou Zhongmei, Knack, Meitheal, Norvium Bioscience, Sandoz, Fresenius Kabi Usa, Hikma, Actavis Totowa, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd V, Ingenus Pharms Llc, Jubilant Generics, L Perrigo Co, Lannett Co Inc, Macleods Pharms Ltd, Mankind Pharma, Mylan Pharms Inc, Orbion Pharms, Rubicon, Sun Pharm Inds Ltd, Teva, Torrent Pharms, Wockhardt Bio Ag, and Baxter Hlthcare Corp, and is included in thirty-eight NDAs. It is available from sixty-nine suppliers. Additional details are available on the PANTOPRAZOLE SODIUM profile page.
The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 209463
| Tradename: | PANTOPRAZOLE SODIUM |
| Applicant: | Hikma |
| Ingredient: | pantoprazole sodium |
| Patents: | 0 |
Pharmacology for NDA: 209463
| Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 209463
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PANTOPRAZOLE SODIUM | pantoprazole sodium | POWDER;INTRAVENOUS | 209463 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9284 | 0143-9284-10 | 10 VIAL in 1 CARTON (0143-9284-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9284-01) |
| PANTOPRAZOLE SODIUM | pantoprazole sodium | POWDER;INTRAVENOUS | 209463 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9300 | 0143-9300-10 | 10 VIAL in 1 CARTON (0143-9300-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9300-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 40MG BASE/VIAL | ||||
| Approval Date: | Jun 30, 2017 | TE: | AP | RLD: | Yes | ||||
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