Details for New Drug Application (NDA): 087693
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NDA 087693 describes ERGOMAR, which is a drug marketed by Pangea and is included in one NDA. It is available from one supplier. Additional details are available on the ERGOMAR profile page.
The generic ingredient in ERGOMAR is ergotamine tartrate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ergotamine tartrate profile page.
The generic ingredient in ERGOMAR is ergotamine tartrate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ergotamine tartrate profile page.
Summary for 087693
| Tradename: | ERGOMAR |
| Applicant: | Pangea |
| Ingredient: | ergotamine tartrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 087693
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERGOMAR | ergotamine tartrate | TABLET;SUBLINGUAL | 087693 | ANDA | TerSera Therapeutics, LLC | 70720-120 | 70720-120-03 | 1 BLISTER PACK in 1 CARTON (70720-120-03) / 3 TABLET in 1 BLISTER PACK |
| ERGOMAR | ergotamine tartrate | TABLET;SUBLINGUAL | 087693 | ANDA | TerSera Therapeutics, LLC | 70720-120 | 70720-120-20 | 2 BLISTER PACK in 1 CARTON (70720-120-20) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 2MG | ||||
| Approval Date: | Feb 24, 1983 | TE: | RLD: | No | |||||
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