Details for New Drug Application (NDA): 018934
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NDA 018934 describes METHYLDOPA, which is a drug marketed by Accord Hlthcare, Chartwell Rx, Duramed Pharms Barr, Halsey, Heritage Pharma, Parke Davis, Pliva, Purepac Pharm, Rising, Roxane, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Par Pharm, Dava Pharms Inc, Ivax Sub Teva Pharms, Sandoz, Abraxis Pharm, Am Regent, Baxter Hlthcare, Hospira, Marsam Pharms Llc, Smith And Nephew, and Teva Parenteral, and is included in ninety-nine NDAs. It is available from two suppliers. Additional details are available on the METHYLDOPA profile page.
The generic ingredient in METHYLDOPA is methyldopate hydrochloride. There are three drug master file entries for this compound. Additional details are available on the methyldopate hydrochloride profile page.
The generic ingredient in METHYLDOPA is methyldopate hydrochloride. There are three drug master file entries for this compound. Additional details are available on the methyldopate hydrochloride profile page.
Summary for 018934
| Tradename: | METHYLDOPA |
| Applicant: | Chartwell Rx |
| Ingredient: | methyldopa |
| Patents: | 0 |
Pharmacology for NDA: 018934
| Mechanism of Action | Adrenergic alpha2-Agonists |
Medical Subject Heading (MeSH) Categories for 018934
Suppliers and Packaging for NDA: 018934
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLDOPA | methyldopa | TABLET;ORAL | 018934 | NDA | Chartwell RX, LLC | 62135-321 | 62135-321-18 | 180 TABLET, FILM COATED in 1 BOTTLE (62135-321-18) |
| METHYLDOPA | methyldopa | TABLET;ORAL | 018934 | NDA | Chartwell RX, LLC | 62135-321 | 62135-321-90 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-321-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Jun 29, 1984 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Jun 29, 1984 | TE: | RLD: | No | |||||
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