Details for New Drug Application (NDA): 091045
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NDA 091045 describes METOPROLOL TARTRATE, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Luitpold, Sandoz, Steriscience, Watson Labs, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Ipca Labs Ltd, Mylan, Norvium Bioscience, Purepac Pharm, Renata, Rubicon, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Youngtech Pharms Inc, Zydus Pharms, Alembic, and Sun Pharm Inds, and is included in thirty-six NDAs. It is available from fifty-four suppliers. Additional details are available on the METOPROLOL TARTRATE profile page.
The generic ingredient in METOPROLOL TARTRATE is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
The generic ingredient in METOPROLOL TARTRATE is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
Summary for 091045
| Tradename: | METOPROLOL TARTRATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | metoprolol tartrate |
| Patents: | 0 |
Pharmacology for NDA: 091045
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 091045
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOPROLOL TARTRATE | metoprolol tartrate | INJECTABLE;INJECTION | 091045 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1365 | 51662-1365-1 | 5 mL in 1 VIAL (51662-1365-1) |
| METOPROLOL TARTRATE | metoprolol tartrate | INJECTABLE;INJECTION | 091045 | ANDA | Fresenius Kabi USA, LLC | 63323-660 | 63323-660-05 | 10 VIAL in 1 TRAY (63323-660-05) / 5 mL in 1 VIAL (63323-660-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Oct 25, 2010 | TE: | AP | RLD: | No | ||||
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