Details for New Drug Application (NDA): 074246
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The generic ingredient in CIMETIDINE is cimetidine hydrochloride. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.
Summary for 074246
Tradename: | CIMETIDINE |
Applicant: | Mylan |
Ingredient: | cimetidine |
Patents: | 0 |
Pharmacology for NDA: 074246
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 074246
Suppliers and Packaging for NDA: 074246
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CIMETIDINE | cimetidine | TABLET;ORAL | 074246 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0053 | 0378-0053-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0053-01) |
CIMETIDINE | cimetidine | TABLET;ORAL | 074246 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0317 | 0378-0317-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0317-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | May 17, 1994 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | May 17, 1994 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | May 17, 1994 | TE: | AB | RLD: | No |
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