Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Yung Shin Pharmaceutical Industrial Co., Ltd.
STERLING KNIGHT PHARMACEUTICALS, LLC
Yung Shin Pharmaceutical Industrual Co., Ltd.
656108149
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meloxicam
Product Details
NDC Product Code
69336-102Application Number
ANDA077918Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2015COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
MeloxicamActive
Code: VG2QF83CGLClass: ACTIBQuantity: 15 mg in 1 1
Meloxicam
Product Details
NDC Product Code
69336-101Application Number
ANDA077918Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2015SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
MeloxicamActive
Code: VG2QF83CGLClass: ACTIBQuantity: 7.5 mg in 1 1