Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Torrent Pharma Inc.
790033935
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Appco Pharma LLC
Torrent Pharmaceuticals Limited
Torrent Pharma Inc.
078510186
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ERYTHROMYCIN
Product Details
NDC Product Code
13668-586Application Number
ANDA211975Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 21, 2021CALCIUM SILICATEInactive
Code: S4255P4G5MClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
ErythromycinActive
Code: 63937KV33DClass: ACTIBQuantity: 250 mg in 1 1
ERYTHROMYCIN
Product Details
NDC Product Code
13668-588Application Number
ANDA211975Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 21, 2021SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CALCIUM SILICATEInactive
Code: S4255P4G5MClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ErythromycinActive
Code: 63937KV33DClass: ACTIBQuantity: 500 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT