Details for New Drug Application (NDA): 087693
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 is one drug master file entry 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 is one drug master file entry 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 |
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 | Pangea Pharmaceuticals LLC | 81279-104 | 81279-104-03 | 1 BLISTER PACK in 1 CARTON (81279-104-03) / 3 TABLET in 1 BLISTER PACK |
| ERGOMAR | ergotamine tartrate | TABLET;SUBLINGUAL | 087693 | ANDA | Pangea Pharmaceuticals LLC | 81279-104 | 81279-104-20 | 2 BLISTER PACK in 1 CARTON (81279-104-20) / 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: | Yes | |||||
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