Is Acetaminophen And Codeine Phosphate still available?

Yes. Acetaminophen And Codeine Phosphate (ANDA 040419) is listed with marketing status Prescription in the FDA Orange Book.

What is Acetaminophen And Codeine Phosphate a generic of?

Acetaminophen And Codeine Phosphate is a generic (ANDA 040419) containing Acetaminophen; Codeine Phosphate. Open the active-ingredient family to see the reference-listed brand and other approved products.

What does Acetaminophen And Codeine Phosphate's TE code AA mean?

AA is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Acetaminophen And Codeine Phosphate substitutable for its reference brand with no expected difference in clinical effect.

What is Acetaminophen And Codeine Phosphate's FDA application number?

Acetaminophen And Codeine Phosphate is approved under ANDA 040419, held by Specgx LLC.

Orange Book product · Generic (ANDA)

Acetaminophen And Codeine Phosphate

Acetaminophen; Codeine Phosphate

Generic (ANDA)ANDA 040419TE AA Specgx LLC

Approved

May 31, 2001

Application

Generic (ANDA)

TE code

Listed patents

Acetaminophen And Codeine Phosphate (Acetaminophen; Codeine Phosphate) is a generic drug approved under an ANDA (040419) in 2001, marketed by Specgx LLC. Its therapeutic-equivalence code is AA, so the FDA considers it substitutable for the reference brand.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
May 31, 2001
25 yr 6 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Strength

300MG;60MG

Dosage form

TABLET

Route

ORAL

TE code

Application

ANDA 040419

Product number

003

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

Yes

Same application

Other strengths in ANDA 040419

Brand + generics

Active-ingredient family

Generic (ANDA) of Acetaminophen; Codeine Phosphate

View full Acetaminophen; Codeine Phosphate family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Acetaminophen And Codeine Phosphate — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Acetaminophen; Codeine Phosphate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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