DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 062677
NDA 062677 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Medicis, Actavis Labs Fl Inc, Alembic Pharms Ltd, Amneal Pharms, Chartwell Life Sci, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Mylan, Par Pharm, Pvt Form, Ranbaxy, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, Zydus Pharms Usa Inc, West-ward Pharms Int, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Amneal Pharms Co, Caribe Holdings, Epic Pharma Llc, Ivax Sub Teva Pharms, Lannett Co Inc, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, and Vintage Pharms, and is included in fifty-four NDAs. It is available from ninety-one suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.
The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Ninety-nine suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Ninety-nine suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 062677
| Tradename: | DOXYCYCLINE HYCLATE |
| Applicant: | Sun Pharm Industries |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
| Therapeutic Class: | Antibacterials Dental and Oral Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 062677
| Ingredient-type | Tetracyclines |
Suppliers and Packaging for NDA: 062677
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 062677 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-923 | N | 43353-923-20 |
| DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 062677 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-923 | N | 43353-923-65 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jul 10, 1986 | TE: | AB | RLD: | No | ||||
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