Application 091650

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE	No	No
002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 20MG BASE	No	No
003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 40MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091650-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17
A091650-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17
A091650-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091650-001	AB
A091650-002	AB
A091650-003	AB

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091650-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091650-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091650-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-07-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091650-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091650-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091650-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091650-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091650-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091650-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091650-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091650-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091650-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091650-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091650-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091650-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091650-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091650-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091650-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091650-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091650-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091650-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091650-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091650-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091650-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091650-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091650-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091650-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091650-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091650-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091650-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091650-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091650-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091650-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091650-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091650-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091650-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091650-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091650-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091650-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091650-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091650-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091650-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091650-001	AB	1	`301d65b070ca…`

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Limited	901550e6-22be-68c9-eb86-f85a9c9dd998	2021-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091650 application number: ANDA091650 ndc (product): 55111-121 ndc (product): 55111-123 ndc (product): 55111-122

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 53 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7769	Atorvastatin Calcium	Atorvastatin Calcium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7770	Atorvastatin Calcium	Atorvastatin Calcium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7771	Atorvastatin Calcium	Atorvastatin Calcium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
35356-860	Atorvastatin Calcium	Atorvastatin Calcium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
53808-1008	Atorvastatin Calcium	Atorvastatin Calcium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-1067	Atorvastatin Calcium	Atorvastatin Calcium	State of Florida DOH Central Pharmacy	ANDA	Current
55111-121	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-121	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-121	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-121	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-121	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-121	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-121	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-122	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-122	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-122	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-122	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-122	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-122	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-122	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-123	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-123	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-123	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-123	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-123	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-123	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-123	Atorvastatin Calcium	Atorvastatin Calcium	Dr. Reddy's Laboratories Limited	ANDA	Current
55700-548	Atorvastatin Calcium	Atorvastatin Calcium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-548	Atorvastatin Calcium	Atorvastatin Calcium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-258	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Direct_Rx	ANDA	Current
61919-258	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Direct_Rx	ANDA	Current
61919-258	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Direct_Rx	ANDA	Current
61919-543	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DirectRX	ANDA	Current
61919-916	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DirectRX	ANDA	Current
63739-018	Atorvastatin Calcium	Atorvastatin Calcium	Mckesson Corporation DBA SKY Packaginng	ANDA	Current
63739-018	Atorvastatin Calcium	Atorvastatin Calcium	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-018	Atorvastatin Calcium	Atorvastatin Calcium	Mckesson Corporation DBA SKY Packaginng	ANDA	Current
63739-020	Atorvastatin Calcium	Atorvastatin Calcium	Mckesson Corporation DBA SKY Packaginng	ANDA	Current
63739-020	Atorvastatin Calcium	Atorvastatin Calcium	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-020	Atorvastatin Calcium	Atorvastatin Calcium	Mckesson Corporation DBA SKY Packaginng	ANDA	Current
63739-036	Atorvastatin Calcium	Atorvastatin Calcium	Mckesson Corporation DBA SKY Packaginng	ANDA	Current
63739-036	Atorvastatin Calcium	Atorvastatin Calcium	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-036	Atorvastatin Calcium	Atorvastatin Calcium	Mckesson Corporation DBA SKY Packaginng	ANDA	Current
67296-1143	Atorvastatin Calcium	Atorvastatin Calcium	RedPharm Drug, Inc.	ANDA	Current
67296-1143	Atorvastatin Calcium	Atorvastatin Calcium	RedPharm Drug, Inc.	ANDA	Current
67296-1143	Atorvastatin Calcium	Atorvastatin Calcium	RedPharm Drug, Inc.	ANDA	Current
68788-6331	Atorvastatin Calcium	Atorvastatin Calcium	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0383	Atorvastatin Calcium	Atorvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-1589	Atorvastatin Calcium	Atorvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-1589	Atorvastatin Calcium	Atorvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70934-201	Atorvastatin Calcium	Atorvastatin Calcium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-201	Atorvastatin Calcium	Atorvastatin Calcium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
76519-1075	Atorvastatin Calcium	Atorvastatin Calcium	H.J. Harkins Company Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65846	ORIG	2021-01-07