Details for New Drug Application (NDA): 213075
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NDA 213075 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, 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, Caribe Holdings, 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-one NDAs. It is available from sixty-five 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 213075
| Tradename: | DOXYCYCLINE HYCLATE |
| Applicant: | Alembic |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213075
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 213075 | ANDA | Alembic Pharmaceuticals Limited | 46708-481 | 46708-481-31 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-481-31) |
| DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 213075 | ANDA | Alembic Pharmaceuticals Limited | 46708-481 | 46708-481-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-481-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Jan 3, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jan 3, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jan 3, 2022 | TE: | AB | RLD: | No | ||||
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