Details for New Drug Application (NDA): 078642
✉ Email this page to a colleague
The generic ingredient in FAMOTIDINE PRESERVATIVE FREE is famotidine. There are eighteen drug master file entries for this compound. One hundred and thirty-nine suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 078642
Tradename: | FAMOTIDINE PRESERVATIVE FREE |
Applicant: | Mylan Labs Ltd |
Ingredient: | famotidine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078642
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078642
Suppliers and Packaging for NDA: 078642
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE PRESERVATIVE FREE | famotidine | INJECTABLE;INJECTION | 078642 | ANDA | Mylan Institutional LLC | 67457-433 | 67457-433-22 | 25 VIAL in 1 CARTON (67457-433-22) / 2 mL in 1 VIAL (67457-433-00) |
FAMOTIDINE PRESERVATIVE FREE | famotidine | INJECTABLE;INJECTION | 078642 | ANDA | Medical Purchasing Solutions, LLC | 71872-7220 | 71872-7220-1 | 1 VIAL in 1 BAG (71872-7220-1) / 2 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
Approval Date: | Jun 25, 2008 | TE: | AP | RLD: | No |
Complete Access Available with Subscription