Details for New Drug Application (NDA): 075591
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NDA 075591 describes FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, which is a drug marketed by Abbvie and Baxter Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER profile page.
The generic ingredient in FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER is famotidine. There are eighteen drug master file entries for this compound. One hundred and thirty-seven suppliers are listed for this compound. Additional details are available on the famotidine profile page.
The generic ingredient in FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER is famotidine. There are eighteen drug master file entries for this compound. One hundred and thirty-seven suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 075591
| Tradename: | FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | famotidine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075591
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 075591
Suppliers and Packaging for NDA: 075591
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER | famotidine | INJECTABLE;INJECTION | 075591 | ANDA | Baxter Healthcare Corporation | 0338-5197 | 0338-5197-41 | 12 BAG in 1 CARTON (0338-5197-41) / 50 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.4MG/ML | ||||
| Approval Date: | May 10, 2001 | TE: | RLD: | No | |||||
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