Details for New Drug Application (NDA): 065425
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The generic ingredient in DEMECLOCYCLINE HYDROCHLORIDE is demeclocycline hydrochloride. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the demeclocycline hydrochloride profile page.
Summary for 065425
Tradename: | DEMECLOCYCLINE HYDROCHLORIDE |
Applicant: | Amneal Pharm |
Ingredient: | demeclocycline hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 065425
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEMECLOCYCLINE HYDROCHLORIDE | demeclocycline hydrochloride | TABLET;ORAL | 065425 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-554 | 53746-554-01 | 100 TABLET in 1 BOTTLE (53746-554-01) |
DEMECLOCYCLINE HYDROCHLORIDE | demeclocycline hydrochloride | TABLET;ORAL | 065425 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-555 | 53746-555-48 | 48 TABLET in 1 BOTTLE (53746-555-48) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Feb 27, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Feb 27, 2008 | TE: | AB | RLD: | No |
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