Details for New Drug Application (NDA): 020238
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NDA 020238 describes TAGAMET HB, which is a drug marketed by Medtech Products and Glaxosmithkline and is included in two NDAs. It is available from two suppliers. Additional details are available on the TAGAMET HB profile page.
The generic ingredient in TAGAMET HB is cimetidine. There are twenty-five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cimetidine profile page.
The generic ingredient in TAGAMET HB is cimetidine. There are twenty-five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cimetidine profile page.
Summary for 020238
| Tradename: | TAGAMET HB |
| Applicant: | Medtech Products |
| Ingredient: | cimetidine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020238
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 020238
Suppliers and Packaging for NDA: 020238
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAGAMET HB | cimetidine | TABLET;ORAL | 020238 | NDA | Prestige Brands Holdings, Inc. | 52183-223 | 52183-223-30 | 3 BLISTER PACK in 1 BOX (52183-223-30) / 10 TABLET in 1 BLISTER PACK |
| TAGAMET HB | cimetidine | TABLET;ORAL | 020238 | NDA | Medtech Products Inc. | 63029-222 | 63029-222-01 | 1 BLISTER PACK in 1 BOX (63029-222-01) / 30 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 19, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 21, 1996 | TE: | RLD: | Yes | |||||
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