Details for New Drug Application (NDA): 077355
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NDA 077355 describes FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE, which is a drug marketed by Perrigo R And D and is included in two NDAs. It is available from eighteen suppliers. Additional details are available on the FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE profile page.
The generic ingredient in FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
The generic ingredient in FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 077355
| Tradename: | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE |
| Applicant: | Perrigo R And D |
| Ingredient: | calcium carbonate; famotidine; magnesium hydroxide |
| Patents: | 0 |
Pharmacology for NDA: 077355
Suppliers and Packaging for NDA: 077355
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 077355 | ANDA | L. Perrigo Company | 0113-0032 | 0113-0032-63 | 25 TABLET, CHEWABLE in 1 BOTTLE (0113-0032-63) |
| FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 077355 | ANDA | L. Perrigo Company | 0113-6023 | 0113-6023-63 | 1 BOTTLE in 1 CARTON (0113-6023-63) / 25 TABLET, CHEWABLE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 800MG;10MG;165MG | ||||
| Approval Date: | Feb 6, 2008 | TE: | RLD: | No | |||||
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