Details for New Drug Application (NDA): 017558
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NDA 017558 describes ROBINUL, which is a drug marketed by Hikma, Robins Ah, and Casper Pharma Llc, and is included in three NDAs. It is available from five suppliers. Additional details are available on the ROBINUL profile page.
The generic ingredient in ROBINUL is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
The generic ingredient in ROBINUL is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 017558
| Tradename: | ROBINUL |
| Applicant: | Hikma |
| Ingredient: | glycopyrrolate |
| Patents: | 0 |
Pharmacology for NDA: 017558
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 017558
Suppliers and Packaging for NDA: 017558
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROBINUL | glycopyrrolate | INJECTABLE;INJECTION | 017558 | NDA | West-Ward Pharmaceuticals Corp. | 0641-6104 | 0641-6104-25 | 25 VIAL in 1 CARTON (0641-6104-25) / 1 mL in 1 VIAL (0641-6104-01) |
| ROBINUL | glycopyrrolate | INJECTABLE;INJECTION | 017558 | NDA | West-Ward Pharmaceuticals Corp. | 0641-6105 | 0641-6105-25 | 25 VIAL in 1 CARTON (0641-6105-25) / 2 mL in 1 VIAL (0641-6105-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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