Details for New Drug Application (NDA): 081113
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NDA 081113 describes ERGOLOID MESYLATES, which is a drug marketed by Mutual Pharm, Sun Pharm Industries, Watson Labs, Kv Pharm, Lederle, Superpharm, and Vangard, and is included in twenty NDAs. It is available from one supplier. Additional details are available on the ERGOLOID MESYLATES profile page.
The generic ingredient in ERGOLOID MESYLATES is ergoloid mesylates. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ergoloid mesylates profile page.
The generic ingredient in ERGOLOID MESYLATES is ergoloid mesylates. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ergoloid mesylates profile page.
Summary for 081113
| Tradename: | ERGOLOID MESYLATES |
| Applicant: | Sun Pharm Industries |
| Ingredient: | ergoloid mesylates |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 081113
Suppliers and Packaging for NDA: 081113
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERGOLOID MESYLATES | ergoloid mesylates | TABLET;ORAL | 081113 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-281 | 53489-281-01 | 100 TABLET in 1 BOTTLE, PLASTIC (53489-281-01) |
| ERGOLOID MESYLATES | ergoloid mesylates | TABLET;ORAL | 081113 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-281 | 53489-281-02 | 50 TABLET in 1 BOTTLE, PLASTIC (53489-281-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Oct 31, 1991 | TE: | RLD: | No | |||||
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