FDA Orange Book
Generic for Phoslo Gelcaps
Phoslo Gelcaps contains calcium acetate. 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 Phoslo Gelcaps is calcium acetate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Phoslo Gelcaps products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 667MG | Discontinued | None | 7 | AB |
NDA 021160, held by FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic calcium acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 077728 | AB (A-rated, therapeutically equivalent) | February 26, 2008 | 667MG |
| CHARTWELL RX SCIENCES LLC | 091312 | AB (A-rated, therapeutically equivalent) | June 1, 2012 | 667MG |
| INVAGEN PHARMACEUTICALS INC | 203135 | AB (A-rated, therapeutically equivalent) | February 7, 2013 | 667MG |
| HERITAGE PHARMACEUTICALS INC | 202315 | AB (A-rated, therapeutically equivalent) | June 29, 2015 | 667MG |
| MPP PHARMA LLC | 203179 | AB (A-rated, therapeutically equivalent) | October 26, 2015 | 667MG |
| COHANCE LIFESCIENCES LTD | 211038 | AB (A-rated, therapeutically equivalent) | February 21, 2020 | 667MG |
| ADAPTIS PHARMA PRIVATE LTD | 217205 | AB (A-rated, therapeutically equivalent) | March 13, 2023 | 667MG |
Questions
Is there a generic for Phoslo Gelcaps?
Yes. The generic name for Phoslo Gelcaps is calcium acetate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Phoslo Gelcaps?
The active ingredient in Phoslo Gelcaps is calcium acetate, 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.