Details for New Drug Application (NDA): 215860
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NDA 215860 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-eight 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 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 suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 215860
| Tradename: | PANTOPRAZOLE SODIUM |
| Applicant: | Meitheal |
| Ingredient: | pantoprazole sodium |
| Patents: | 0 |
Pharmacology for NDA: 215860
| Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 215860
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PANTOPRAZOLE SODIUM | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 215860 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-600 | 71288-600-11 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-600-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-600-10) |
| PANTOPRAZOLE SODIUM | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 215860 | ANDA | Northstar Rx LLC | 72603-128 | 72603-128-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (72603-128-10) / 10 mL in 1 VIAL, SINGLE-DOSE (72603-128-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 40MG BASE/VIAL | ||||
| Approval Date: | Aug 29, 2022 | TE: | AP | RLD: | No | ||||
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