Details for New Drug Application (NDA): 216509
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NDA 216509 describes METOPROLOL SUCCINATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alkem Labs Ltd, Cipla, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd Iii, Lupin, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Prinston Inc, Reddys, Sandoz, Sunshine, Visum Pharm, Wockhardt, Yichang Humanwell, Zhejiang Jutai Pharm, and Zydus Pharms, and is included in twenty-seven NDAs. It is available from forty-four suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.
The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 216509
| Tradename: | METOPROLOL SUCCINATE |
| Applicant: | Granules |
| Ingredient: | metoprolol succinate |
| Patents: | 0 |
Pharmacology for NDA: 216509
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 216509
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 216509 | ANDA | Granules India Ltd | 62207-130 | 62207-130-49 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-130-49) |
| METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 216509 | ANDA | Granules India Ltd | 62207-130 | 62207-130-54 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-130-54) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG TARTRATE | ||||
| Approval Date: | Aug 7, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG TARTRATE | ||||
| Approval Date: | Aug 7, 2023 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 100MG TARTRATE | ||||
| Approval Date: | Aug 7, 2023 | TE: | RLD: | No | |||||
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