FDA Orange Book

Generic for Cleocin Phosphate

Cleocin Phosphate contains clindamycin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Cleocin Phosphate is clindamycin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Cleocin Phosphate products in the Orange Book

Cleocin Phosphate products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injectionEQ 150MG BASE/MLMarketed (Rx)AP5AP

NDA 050441, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic clindamycin

Approved generic versions of Cleocin Phosphate
CompanyANDATE codeApprovedStrengths
PFIZER INC062803AP (A-rated, therapeutically equivalent)October 16, 1987EQ 150MG BASE/ML
HIKMA PHARMACEUTICALS USA INC062889AP (A-rated, therapeutically equivalent)April 25, 1988EQ 150MG BASE/ML
HIKMA PHARMACEUTICALS USA INC065206AP (A-rated, therapeutically equivalent)September 24, 2004EQ 150MG BASE/ML
SAGENT PHARMACEUTICALS INC090108AP (A-rated, therapeutically equivalent)September 30, 2011EQ 150MG BASE/ML
SAGENT PHARMACEUTICALS INC090109AP (A-rated, therapeutically equivalent)September 30, 2011EQ 150MG BASE/ML

Cleocin Phosphate NDC codes

Questions

Is there a generic for Cleocin Phosphate?

Yes. The generic name for Cleocin Phosphate is clindamycin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Cleocin Phosphate?

The active ingredient in Cleocin Phosphate is clindamycin, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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