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Details for New Drug Application (NDA): 205931
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NDA 205931 describes ACTICLATE, which is a drug marketed by Almirall and is included in two NDAs. It is available from two suppliers. Additional details are available on the ACTICLATE profile page.
The generic ingredient in ACTICLATE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
The generic ingredient in ACTICLATE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 205931
| Tradename: | ACTICLATE |
| Applicant: | Almirall |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205931
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACTICLATE | doxycycline hyclate | TABLET;ORAL | 205931 | NDA | Actavis Pharma, Inc. | 0591-6100 | 0591-6100-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0591-6100-60) |
| ACTICLATE | doxycycline hyclate | TABLET;ORAL | 205931 | NDA | Actavis Pharma, Inc. | 0591-6125 | 0591-6125-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0591-6125-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Jul 25, 2014 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jul 25, 2014 | TE: | AB | RLD: | Yes | ||||
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