Details for New Drug Application (NDA): 075813
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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 075813
Tradename: | FAMOTIDINE PRESERVATIVE FREE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | famotidine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075813
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 075813
Suppliers and Packaging for NDA: 075813
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE PRESERVATIVE FREE | famotidine | INJECTABLE;INJECTION | 075813 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1375 | 51662-1375-1 | 2 mL in 1 VIAL, SINGLE-DOSE (51662-1375-1) |
FAMOTIDINE PRESERVATIVE FREE | famotidine | INJECTABLE;INJECTION | 075813 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1375 | 51662-1375-2 | 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1375-2) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
Approval Date: | Apr 16, 2001 | TE: | AP | RLD: | No |
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