DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 207289
NDA 207289 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Medicis, Actavis Labs Fl Inc, Ajanta Pharma Ltd, 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 eighty-nine suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.
The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Ninety-seven 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-eight drug master file entries for this compound. Ninety-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 207289
| Tradename: | DOXYCYCLINE HYCLATE |
| Applicant: | Amneal Pharms |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207289
| Ingredient-type | Tetracyclines |
Suppliers and Packaging for NDA: 207289
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 207289 | ANDA | Unit Dose Services | 50436-1100 | 50436-1100-1 | 20 CAPSULE in 1 BOTTLE (50436-1100-1) |
| DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 207289 | ANDA | Bryant Ranch Prepack | 63629-7751 | 63629-7751-1 | 20 CAPSULE in 1 BOTTLE (63629-7751-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jun 27, 2016 | TE: | AB | RLD: | No | ||||
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