Details for New Drug Application (NDA): 208086
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NDA 208086 describes GLUCAGON, which is a drug marketed by Amphastar Pharms Inc, Lilly, and Fresenius Kabi Usa, and is included in four NDAs. It is available from four suppliers. Additional details are available on the GLUCAGON profile page.
The generic ingredient in GLUCAGON is glucagon hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glucagon hydrochloride profile page.
The generic ingredient in GLUCAGON is glucagon hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glucagon hydrochloride profile page.
Summary for 208086
| Tradename: | GLUCAGON |
| Applicant: | Amphastar Pharms Inc |
| Ingredient: | glucagon |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 208086
Suppliers and Packaging for NDA: 208086
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLUCAGON | glucagon | INJECTABLE;INJECTION | 208086 | ANDA | Amphastar Pharmaceuticals, Inc. | 0548-5850 | 0548-5850-00 | 1 KIT in 1 KIT (0548-5850-00) * 1 mL in 1 VIAL (0548-5905-00) * 1 mL in 1 SYRINGE (0548-5831-00) |
| GLUCAGON | glucagon | INJECTABLE;INJECTION | 208086 | ANDA | A-S Medication Solutions | 50090-6550 | 50090-6550-0 | 1 KIT in 1 VIAL (50090-6550-0) / 1 KIT in 1 KIT * 1 mL in 1 VIAL (0548-5905-00) * 1 mL in 1 SYRINGE (0548-5831-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/VIAL | ||||
| Approval Date: | Dec 28, 2020 | TE: | RLD: | No | |||||
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