FDA Orange Book
Generic for Robinul Forte
Robinul Forte contains glycopyrrolate. 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 Robinul Forte is glycopyrrolate. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Robinul Forte products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 2MG | Marketed (Rx) | AA | 12 | AA |
NDA 012827, held by CASPER PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic glycopyrrolate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 040653 | AA (A-rated, therapeutically equivalent) | August 31, 2006 | 2MG |
| CHARTWELL RX SCIENCES LLC | 040847 | AA (A-rated, therapeutically equivalent) | March 21, 2008 | 2MG |
| RISING PHARMA HOLDINGS INC | 040821 | AA (A-rated, therapeutically equivalent) | December 29, 2008 | 2MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 040844 | AA (A-rated, therapeutically equivalent) | August 18, 2009 | 2MG |
| TP ANDA HOLDINGS LLC | 090020 | AA (A-rated, therapeutically equivalent) | October 19, 2011 | 2MG |
| VELZEN PHARMA PVT LTD | 090195 | AA (A-rated, therapeutically equivalent) | September 21, 2012 | 2MG |
| REGCON HOLDINGS LLC | 091182 | AA (A-rated, therapeutically equivalent) | February 3, 2014 | 2MG |
| NATCO PHARMA LTD | 091413 | AA (A-rated, therapeutically equivalent) | June 20, 2016 | 2MG |
| APPCO PHARMA LLC | 207201 | AA (A-rated, therapeutically equivalent) | January 3, 2017 | 2MG |
| AUROBINDO PHARMA LTD | 202675 | AA (A-rated, therapeutically equivalent) | October 30, 2018 | 2MG |
| ALEMBIC PHARMACEUTICALS LTD | 203657 | AA (A-rated, therapeutically equivalent) | November 30, 2018 | 2MG |
| QUAGEN PHARMACEUTICALS LLC | 212696 | AA (A-rated, therapeutically equivalent) | July 10, 2024 | 2MG |
Robinul Forte NDC codes
Questions
Is there a generic for Robinul Forte?
Yes. The generic name for Robinul Forte is glycopyrrolate. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Robinul Forte?
The active ingredient in Robinul Forte is glycopyrrolate, 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.