Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Pharmaceuticals USA Inc.
156861945
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc.
650461283
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rivastigmine
Product Details
NDC Product Code
70710-1197Application Number
ANDA206318Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
October 3, 2022RivastigmineActive
Code: PKI06M3IW0Class: ACTIBQuantity: 9.5 mg in 24 h
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37XClass: IACT
POLYISOBUTYLENE (55000 MW)Inactive
Code: TQ77WR8A02Class: IACT
Rivastigmine
Product Details
NDC Product Code
70710-1196Application Number
ANDA206318Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
October 3, 2022POLYISOBUTYLENE (55000 MW)Inactive
Code: TQ77WR8A02Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37XClass: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT
RivastigmineActive
Code: PKI06M3IW0Class: ACTIBQuantity: 4.6 mg in 24 h
Rivastigmine
Product Details
NDC Product Code
70710-1198Application Number
ANDA206318Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
October 3, 2022RivastigmineActive
Code: PKI06M3IW0Class: ACTIBQuantity: 13.3 mg in 24 h
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYISOBUTYLENE (55000 MW)Inactive
Code: TQ77WR8A02Class: IACT