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Pilocarpine Hydrochloride

Pilocarpine Hydrochloride TabletsRx Only

Approved
Approval ID

ecd2428e-b471-4dba-9b22-a81af4065d5a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 2, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pilocarpine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5436
Application NumberANDA077220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2011
FDA Product Classification

INGREDIENTS (7)

STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PILOCARPINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT

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Pilocarpine Hydrochloride - FDA Drug Approval Details