| Product Information |
|
| Registration Number |
DRP-11059
|
| Generic Name |
Ketoanalogues + Essential Amino Acids
|
| Brand Name |
Ketonov
|
| Dosage Strength |
Formulation: Each film-coated tablet contains Calcium-3-methyl-2-oxo-valerate................67 mg (a-Ketoanalogue to Isoleucine, calcium salt) Calcium-4-methyl-2-Oxo-valerate ..................101 mg (C-Ketoanalogue to Leucine, calcium salt) Calcium-2-oxo-3-Phenylpropionate ..............68 mg (a-Ketoanalogue to Phenylalanine, calcium salt) Calcium-3-methyl-2-oxo-butyrate ................86 mg (a-Ketoanalogue to Valine, calcium salt)
Calcium-DL-2-hydroxy-4(methylthio) butyrate...59 mg (a-hydroxyanalogue to Methionine, calcium salt) L-Lysine acetate USP........... 105 mg L-Threonine USP ..........53 mg L-Tryptophan USP ..............23 mg L-Histidine USP..................38 mg L-Tyrosine USP ...................30 mg Excipients ........qs.
|
| Dosage Form |
Film-Coated Tablet
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Renal Nutrition Therapy
|
| Packaging |
Alu-Alu Blister pack x 10's (Box of 30's & 100's)
|
| Manufacturer |
Celogen Generics Private Ltd. (Unit II)
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Medinova Pharmaceutical Inc.
|
| Distributor |
Medinova Pharmaceutical Inc.
|
| Application Type |
Initial
|
| Issuance Date |
21 January 2022
|
| Expiry Date |
21 January 2027
|