Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pilocarpine hydrchloride
Product Details
NDC Product Code
71335-2120Application Number
ANDA076746Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 8, 2023MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PilocarpineActive
Code: 0WW6D218XJClass: ACTIBQuantity: 5 mg in 1 1