triamcinolone acetonide
- Product NDC
- 68788-6795
- 11-digit product format
- 687886795
- Labeler code
- 68788
- Product ID
- 68788-6795_57a4a8a0-958a-4a47-85f7-d9f546897bc3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- triamcinolone acetonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals
- Application
- ANDA085692
- Marketing category
- ANDA
- Marketing start
- 2018-02-15
- Marketing end
- 0000-00-00
- Substance
- TRIAMCINOLONE A
- Active strength
- 5 mg/g
- Pharmacologic classes
- Corticosteroid
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68788-6795 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 68788-6795 | 68788-6795-1 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-6795-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-6795-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-6795-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-6795-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-6795-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-6795-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-6795-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-6795-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-6795-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-6795-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-6795-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-6795-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A085692-001 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | |
| A085692-002 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | |
| A085692-003 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A085692-001 | AT |
| A085692-002 | AT |
| A085692-003 | AT |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A085692-001 | AT | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A085692-002 | AT | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A085692-003 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A085692-001 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085692-002 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085692-003 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-001 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-002 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-003 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-001 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-002 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-003 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-001 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-002 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-003 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-001 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-002 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-003 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-001 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-002 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-003 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-001 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-002 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-003 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-002 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-003 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-001 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-002 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-003 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-001 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-002 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-003 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-001 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-002 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-003 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-001 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-002 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-003 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085692-001 | AT | 1 | 1e350fbaab3a… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | DIRECTRX | 835bbcd1-3869-646c-e053-2a91aa0a796a | 2026-03-17 | Adverse reactions | 085692 ANDA085692 |
| triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 92a1ded0-8e1a-4994-9c8a-89e84fc85c94 | 2026-01-28 | Adverse reactions | 085692 ANDA085692 |
| triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | 5701a07f-bd22-4bc7-95ff-0c5444ea5971 | 2025-10-01 | Adverse reactions | 085692 ANDA085692 |
| triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | 5040eba2-2d00-496a-8773-66ba5440610f | 2025-06-27 | Adverse reactions | 085692 ANDA085692 |
| triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 2d6b9c2f-f1a0-413e-b333-64da52368202 | 2023-12-09 | Adverse reactions | 085692 ANDA085692 |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Proficient Rx LP | 41c1fe93-0509-4cf6-ac35-049028b731de | 2019-12-01 | Adverse reactions | 085692 ANDA085692 |