Details for New Drug Application (NDA): 210536
✉ Email this page to a colleague
NDA 210536 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Strides Pharma, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Endo Operations, Gland Pharma Ltd, Heritage, Kindos, Lupin Ltd, Slate Run Pharma, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Lupin, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, and Torrent, and is included in eighty-two NDAs. It is available from sixty-six 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. Seventy-four 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. Seventy-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 210536
| Tradename: | DOXYCYCLINE HYCLATE |
| Applicant: | Alembic |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210536
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 210536 | ANDA | Alembic Pharmaceuticals Limited | 46708-353 | 46708-353-20 | 20 TABLET, FILM COATED in 1 BOTTLE (46708-353-20) |
| DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 210536 | ANDA | Alembic Pharmaceuticals Limited | 46708-353 | 46708-353-50 | 50 TABLET, FILM COATED in 1 BOTTLE (46708-353-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | May 14, 2020 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Sep 14, 2021 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
