Paxil Cr

   
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Paxil Cr


Drug - Paxil Cr
The trade name of the product as shown on the labeling.

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Paroxetine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 12.5MG BASE
The potency of the active ingredient(s), Paroxetine Hydrochloride. May repeat for multiple part products.

Applicant - GLAXOSMITHKLINE
The firm name holding legal responsibility for Paxil Cr. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020936
The FDA assigned number to Paxil Cr. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Paxil Cr. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Feb 16, 1999
The date Paxil Cr was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Paxil Cr. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Paxil Cr is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Paxil Cr.

Paxil Cr


Paxil Cr Eq 12.5mg Base Tablet, Extended Release; Oral
Humatin Eq 250mg Base Capsule; Oral
Humatin Eq 250mg Base Capsule; Oral
Paromomycin Sulfate Eq 250mg Base Capsule; Oral
Humatin Eq 125mg Base/5ml Syrup; Oral
Paxil Eq 10mg Base **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Paxil Eq 20mg Base **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Paxil Eq 30mg Base **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Paxil Eq 40mg Base **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Paxil Eq 10mg Base/5ml Suspension; Oral

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