Astramorph Pf

   
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Astramorph Pf


Drug - Astramorph Pf
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Morphine Sulfate
Multiple ingredients are in alphabetical order.

Strength - 1MG/ML
The potency of the active ingredient(s), Morphine Sulfate. May repeat for multiple part products.

Applicant - ASTRAZENECA
The firm name holding legal responsibility for Astramorph Pf. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 071052
The FDA assigned number to Astramorph Pf. Format is nnnnnn.

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

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

Approval Date - Oct 7, 1986
The date Astramorph Pf 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 Astramorph Pf. 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 Astramorph Pf is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astrazeneca Lp
The full name of the firm holding legal responsibility for the new application of Astramorph Pf.

Astramorph Pf