| Acetaminophen; Butalbital | Oral | Capsule | 088831 | Minor Revision: Remove recommendation on a strength due to safety concerns | Non- Complex | 02/2024 |
| Aclidinium Bromide | Inhalation | Powder, Metered | 202450 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 05/2024 |
| Aclidinium Bromide; Formoterol Fumarate | Inhalation | Powder, Metered | 210595 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 05/2024 |
| Albuterol Sulfate | Inhalation | Powder, Metered | 205636 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 05/2024 |
| Albuterol Sulfate | Inhalation | Aerosol, Metered | 020503, 020983, 021457 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 11/2023 |
| Albuterol Sulfate; Ipratropium Bromide | Inhalation | Spray, Metered | 021747 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 08/2024 |
| Azelaic Acid | Topical | Gel | 021470 | Minor Revision: Add an in vitro BE option | Complex | 05/2024 |
| Betamethasone Acetate; Betamethasone Sodium Phosphate | Injection | Injectable | 014602 | Editorial: Correct Typos
Minor: Change in study design for in vivo BE study(ies); Add an in vitro BE option
| Complex | 11/2023 |
| Budesonide | Inhalation | Powder, Metered | 021949 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons
| Complex | 05/2024 |
| Budesonide; Formoterol Fumarate Dihydrate | Inhalation | Aerosol, Metered | 021929 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 11/2023 |
| Doxepin Hydrochloride | Oral | Tablet | 022036 | Minor Revision: Reorganize to include all strengths within a single PSG; Add an in vitro BE option | Non- Complex | 02/2024 |
| Emtricitabine; Tenofovir Alafenamide Fumarate | Oral | Tablet | 208215 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD | Non- Complex | 11/2023 |
| Ferric Carboxymaltose | Intravenous | Solution | 203565 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS | Complex | Within the next 12 months |
| Ferumoxytol | Intravenous | Solution | 022180 | Editorial Revision: Correct typos; Update the language
Minor Revision: Clarify in vivo study design | Complex | Within the next 12 months |
| Fluorouracil | Cream | Topical | 020985 | Minor Revision: Add an in vitro BE option | Complex | Beyond 12 months |
| Fluticasone Furoate | Inhalation | Powder | 205625 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 02/2024 |
| Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Inhalation | Powder | 209482 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 02/2024 |
| Fluticasone Furoate; Vilanterol Trifenatate | Inhalation | Powder | 204275 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparison | Complex | 02/2024 |
| Fluticasone Propionate | Inhalation | Aerosol, Metered | 021433 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 11/2023 |
| Fluticasone Propionate | Inhalation | Powder | 020833 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 02/2024 |
| Fluticasone Propionate | Inhalation | Powder | 208798 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 05/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | Inhalation | Aerosol, Metered | 021254 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 11/2023 |
| Fluticasone Propionate; Salmeterol Xinafoate | Inhalation | Powder | 021077 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 02/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | Inhalation | Powder | 208799 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 05/2024 |
| Fulvestrant | Intramuscular | Solution | 021344 | Editorial Revision: Update the language
Minor Revision: Add recommendations for device comparisons | Non- Complex | 11/2023 |
| Gabapentin | Oral | Tablet | 022544 | In Vivo Major Revision: Add an in vivo study | Non- Complex | 11/2023 |
| Glatiramer Acetate | Subcutaneous | Injectable | 020622 | Editorial Revision: Update the language
Minor Revision: Add recommendations for device comparisons | Complex | 11/2023 |
| Lanreotide Acetate | Subcutaneous | Solution | 022074 | Editorial Revision: Update the language
Minor Revision: Add recommendations for device comparisons | Complex | Beyond 12 months |
| Levalbuterol Tartrate | Inhalation | Aerosol, Metered | 021730 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 11/2023 |
| Levonorgestrel | Intrauterine | Intrauterine Device | 203159 | Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | Within the next 12 months |
| Mometasone Furoate | Inhalation | Aerosol, Metered | 205641 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 11/2023 |
| Mometasone Furoate | Inhalation | Powder | 021067 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 05/2024 |
| Naltrexone | Intramuscular | For Suspension, Extended Release | 021897 | Editorial Revision: Correct Typos
Minor Revision: Add recommendations for device comparisons | Complex | 11/2023 |
| Olodaterol Hydrochloride | Inhalation | Spray, Metered | 203108 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 08/2024 |
| Olodaterol Hydrochloride; Tiotropium Bromide | Inhalation | Spray, Metered | 206756 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 08/2024 |
| Primidone | Oral | Tablet | 009170 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS | Non- Complex | 11/2023 |
| Salmeterol Xinafoate | Inhalation | Powder | 020692 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 02/2024 |
| Semaglutide | Subcutaneous | Solution | 209637 | Minor Revision: Add recommendations for device comparisons | Complex | 11/2023 |
| Sotorasib | Oral | Tablet | 214665 | In Vivo Major Revision: Change in study design for in vivo BE study(ies) | Non- Complex | 11/2023 |
| Soybean Oil | Injection | Injectable | 017643; 018449; 020248 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS; Add recommendations for device comparisons | Complex | 11/2023 |
| Soybean Oil | Injection | Injectable | 019531 | Minor Revision: Add recommendations for device comparisons | Complex | 11/2024 |
| Tiotropium Bromide | Inhalation | Powder | 021395 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 11/2023 |
| Tiotropium Bromide | Inhalation | Spray, Metered | 021936 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 08/2024 |
| Umeclidinium Bromide | Inhalation | Powder | 205382 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 02/2024 |
| Umeclidinium Bromide; Vilanterol Trifenatate | Inhalation | Powder | 203975 | Editorial Revision: Update the language
Minor Revision: Clarify in vivo and in vitro study designs; Revise recommendations for device comparisons | Complex | 02/2024 |
| Vandetanib | Oral | Tablet | 022405 | In Vitro Major Revision: Add an in vitro study(ies) | Non- Complex | 02/2024 |