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Details for New Drug Application (NDA): 075967
The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-eight drug master file entries for this compound. One hundred and twelve suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 075967
Tradename: | METFORMIN HYDROCHLORIDE |
Applicant: | Sun Pharm Inds Inc |
Ingredient: | metformin hydrochloride |
Patents: | 0 |
Therapeutic Class: | Blood Glucose Regulators |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075967
Ingredient-type | Biguanides |
Medical Subject Heading (MeSH) Categories for 075967
Suppliers and Packaging for NDA: 075967
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET;ORAL | 075967 | ANDA | Rebel Distributors Corp. | 21695-471 | E | 21695-471-90 |
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET;ORAL | 075967 | ANDA | Rebel Distributors Corp. | 21695-471 | E | 21695-471-00 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 29, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 850MG | ||||
Approval Date: | Jan 29, 2002 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
Approval Date: | Jan 29, 2002 | TE: | AB | RLD: | No |
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