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Medroxyprogesterone Acetate

MEDROXYPROGESTERONE ACETATE TABLETS, USP

Approved
Approval ID

e5f5c46c-b8b7-4502-9d2b-8f12284d1a63

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 4, 2010

Manufacturers
FDA

Rebel Distributors Corp.

DUNS: 118802834

Products 1

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

Medroxyprogesterone Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-896
Application NumberANDA040159
Product Classification
M
Marketing Category
C73584
G
Generic Name
Medroxyprogesterone Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2008
FDA Product Classification

INGREDIENTS (7)

sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
MEDROXYPROGESTERONE ACETATEActive
Quantity: 10 mg in 1 1
Code: C2QI4IOI2G
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Medroxyprogesterone Acetate - FDA Drug Approval Details