Details for New Drug Application (NDA): 071081
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NDA 071081 describes MECLOFENAMATE SODIUM, which is a drug marketed by Am Therap, Ani Pharms, Barr, Chartwell Rx, Mylan, Par Pharm, Usl Pharma, Vitarine, and Watson Labs, and is included in eighteen NDAs. It is available from one supplier. Additional details are available on the MECLOFENAMATE SODIUM profile page.
The generic ingredient in MECLOFENAMATE SODIUM is meclofenamate sodium. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meclofenamate sodium profile page.
The generic ingredient in MECLOFENAMATE SODIUM is meclofenamate sodium. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meclofenamate sodium profile page.
Summary for 071081
| Tradename: | MECLOFENAMATE SODIUM |
| Applicant: | Mylan |
| Ingredient: | meclofenamate sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 071081
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MECLOFENAMATE SODIUM | meclofenamate sodium | CAPSULE;ORAL | 071081 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2150 | 0378-2150-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2150-01) |
| MECLOFENAMATE SODIUM | meclofenamate sodium | CAPSULE;ORAL | 071081 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3000 | 0378-3000-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3000-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Sep 3, 1986 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Sep 3, 1986 | TE: | RLD: | No | |||||
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