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Meprobamate

Meprobamate Tablets

Approved
Approval ID

d6fa7f20-5125-ff79-4e8d-00542a13472a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 9, 2009

Manufacturers
FDA

Dr.Reddy's Laboratories Limited

DUNS: 862179079

Products 2

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

Meprobamate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55111-640
Application NumberANDA040797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meprobamate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2009
FDA Product Classification

INGREDIENTS (7)

starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
MeprobamateActive
Quantity: 200 mg in 1 1
Code: 9I7LNY769Q
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT

Meprobamate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55111-641
Application NumberANDA040797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meprobamate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2009
FDA Product Classification

INGREDIENTS (6)

starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
MeprobamateActive
Quantity: 400 mg in 1 1
Code: 9I7LNY769Q
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT

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Meprobamate - FDA Drug Approval Details