This brand name is authorized in Nigeria.
The drug OFLOXAMET contains one active pharmaceutical ingredient (API):
1
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UNII
A4P49JAZ9H - OFLOXACIN
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Ofloxacin is a quinolone-carboxylic acid derivative with a wide range of antibacterial activity against both Gram-negative and Gram-positive organisms. The primary mode of action of the quinolones is the specific inhibition of bacterial DNA gyrase. This enzyme is required for DNA replication, transcription, repair and recombination. |
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This drug has been approved in Nigeria as follows:
Identifier | Form | Presentation | Description | Approval |
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B4-6547 | Tablet | Ofloxamet 200 tablet TAB 200 mg | OFLOXAMET 200 TABLET B4-6547 OFLOXAMET 200 TABLET OFLOXACIN USP 200mg ,TALIC MAIZE STARCH PURITY EXCIPIENT: MAIZE STARCH, DIBASIC CALCIUM PHOPHATE, GELATINE, MRTHYL PARABEN (METHYL HYDROXY BENZOATE), PROPYL PARABEN (PROPYL HYDROXY BENZOATE), MICROCRYSTALLINE CELLULOSE (PLAIN), SODIUM STARCH GLYCOLATE, MAGNESIUM STEARATE, TALCUM (PURIFIED TALE), COLLOIDAL SILICON DIOXIDE (COLLOIDAL ANHYDROUS SILICA), H.P.M.C.E 15 (HYPROMELLOSE), TITANIUM DIOXIDE, PURIFIED TALE (TALCUM), P.E.G 6000 (MACROGOL) Tablet Prescription Only Medicine (POM) MAYDON PHARMACEUTICAL LIMITED., WILMER STREET, OFF TOWN PLANNING, ILUPEJU, LAGOS LAGOS Nigeria RHYDBURG PHARM. LTD, C 2& 3 SIEL SELAQUI DEHRADUN UTTARAKHAND, INDIA, India 26/01/2023 25/01/2028 | 26/01/2023 |
B4-6548 | Tablet | Ofloxamet tablet 400mg TAB 400 mg | OFLOXAMET TABLETS 400MG B4-6548 OFLOXAMET TABLETS 400MG OFLOXACIN USP 400MG EXCIPIENTS: MAIZE STARCH, DIBASIC CALCIUM PHOSPHATE, GELATINE, METHYL PARABEN (MRTHYL HYDOXY BENZOATE) PROPYL PARABEN (PROPYL HYDROXY BENZOATE) SODIUM STARCH GLYCOLATE, COLLOIDAL SILICON DIOXIDE (LIGHT) MAGNESIUM STEARATE, TALCUM, CROSS CARMELLOSE SODIUM (VIVASOLE) MICROCRYSTALIINE CELLULOSE (PH 102), TITANIUM DIOXIDE, PURIFIED TALE (TALCUM) P.E.G. 6000 (MACTOGOL). H.P.M.C.E 15 (HYPROMELLOSE) Prescription Only Medicine (POM) MAYDON PHARMACEUTICAL LIMITED., WILMER STREET, OFF TOWN PLANNING, ILUPEJU, LAGOS LAGOS GLOBELA PHARMA PVT. LTD., 357, G.I.D.C., SACHIN, SURAT-394230,GUJARAT, INDIA., India 23/02/2023 22/02/2028 | 23/02/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
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J01MA01 | Ofloxacin | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01M Quinolone antibacterials → J01MA Fluoroquinolones |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
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NG | Registered Drug Product Database | B4-6547, B4-6548 |
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