DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 075967
NDA 075967 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Alignscience Pharma, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cspc Ouyi Pharm Co, Granules India Ltd, Impax Labs, Intellipharmaceutics, Inventia Hlthcare, Ivax Sub Teva Pharms, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Mylan, Mylan Pharms Inc, Nostrum Labs Inc, Nostrum Pharms Llc, Ranbaxy Labs Ltd, Sandoz, Sun Pharm Inds (in), Sun Pharm Industries, Sun Pharma Global, Teva, Torrent Pharms Ltd, Watson Labs Inc, Zydus Pharms Usa, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell Life Sci, Dr Reddys Labs Inc, Glenmark Generics, Granules India, Indicus Pharma, Ipca Labs Ltd, Provident Pharm, Sciegen Pharms Inc, Sun Pharm Inds Inc, Torrent Pharms, Watson Labs, Watson Labs Florida, and Zydus Hlthcare, and is included in seventy-five NDAs. It is available from one hundred and six suppliers. Additional details are available on the METFORMIN HYDROCHLORIDE profile page.
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.
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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